85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details


臨床試験数 : 598 薬物数 : 444 - (DrugBank : 116) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 209

  
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT03800017
(ClinicalTrials.gov)
September 1, 202221/11/2018Skeletal Muscle Function in Interstitial Lung DiseaseInvestigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung DiseaseInterstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Hypersensitivity Pneumonitis;Scleroderma;Nonspecific Interstitial PneumoniaBiological: HyperoxiaUniversity of British ColumbiaNULLNot yet recruiting40 Years80 YearsAll40N/ANULL
2NCT05255991
(ClinicalTrials.gov)
September 202215/2/2022Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-2)Idiopathic Pulmonary Fibrosis;Interstitial Lung DiseaseDrug: Placebo;Drug: Inhaled Treprostinil;Device: Treprostinil Ultrasonic NebulizerUnited TherapeuticsNULLNot yet recruiting40 YearsN/AAll396Phase 3NULL
3NCT04905693
(ClinicalTrials.gov)
June 202220/5/2021Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisAn Open-label Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Interstitial Lung DiseaseDrug: Inhaled Treprostinil;Device: Treprostinil Ultrasonic NebulizerUnited TherapeuticsNULLNot yet recruiting40 YearsN/AAll792Phase 3NULL
4NCT05195918
(ClinicalTrials.gov)
April 1, 20222/12/2021Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF PatientsDose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug EffectIdiopathic Pulmonary FibrosisCombination Product: EGCG + Nintedanib;Combination Product: EGCG + Pirfenidone;Combination Product: Placebo + Nintedanib or PirfenidoneHal ChapmanUniversity of Michigan;Cornell University;Massachusetts General Hospital;Temple UniversityNot yet recruiting40 Years85 YearsAll50Phase 1United States
5EUCTR2021-001253-32-GR
(EUCTR)
04/03/202227/12/2021A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Other descriptive name: SAR100842
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;South Africa;Germany;Netherlands;Korea, Republic of
6NCT05241275
(ClinicalTrials.gov)
March 1, 20223/2/2022Xenon MRI and Progressive ILDXENON ILD: 129Xe MRI to Evaluate aNtifibrotic respOnse and progressioN in ILDIdiopathic Pulmonary Fibrosis;Progressive Pulmonary FibrosisDrug: Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis TreatmentDuke UniversityBoehringer IngelheimNot yet recruiting18 YearsN/AAll75Phase 2NULL
7NCT05154240
(ClinicalTrials.gov)
February 21, 202217/11/2021A Phase 1, Evaluate the Safety, Tolerability, and Pharmacokinetics of INS018_055 in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Oral Single and Multiple Ascending Doses, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INS018_055 in Healthy SubjectsIdiopathic Pulmonary FibrosisDrug: INS018_055;Drug: PlaceboInSilico Medicine Hong Kong LimitedNULLNot yet recruiting18 Years55 YearsAll80Phase 1New Zealand
8EUCTR2021-001253-32-ES
(EUCTR)
16/02/202207/12/2021A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Other descriptive name: SAR100842
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Korea, Republic of
9NCT05016817
(ClinicalTrials.gov)
February 202217/8/2021Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPFSafety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: AlloRxThe Foundation for Orthopaedics and Regenerative MedicineNULLRecruitingN/AN/AAll20Phase 1Antigua and Barbuda
10NCT05130970
(ClinicalTrials.gov)
January 27, 202212/11/2021CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: CSL312;Drug: PlaceboCSL BehringNULLRecruiting40 YearsN/AAll80Phase 2United States;Canada
11JPRN-jRCT2051210169
16/01/202205/02/2022A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary FibrosisPamrevlumab or placebo, 30 mg/kg, IV, Day 1 and every 3 weeks thereafter, up to Week 48, for a total of up to 17 infusions.Tracy GanskeNULLRecruiting>= 40age old<= 85age oldBoth34Phase 3United States;Argentina;Chile;Russia;Australia;Taiwan;Hong Kong;South Korea;the People's Republic of China;Japan
12JPRN-jRCT2001210001
06/01/202226/12/2021A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) - WA42294 Idiopathic pulmonary fibrosisPatients will receive IV infusions of 10 mg/kg PRM-151 over 50-70 minutes, with dose based on the patients weight recorded at each visitShimoda YukikoNULLPending>= 40age oldNot applicableBoth60Phase 3Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;South Korea;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Russian Federation;Singapore;South Africa;Spain;Sweden;Japan
13NCT04677426
(ClinicalTrials.gov)
January 1, 202216/12/2020129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study129Xe Gas Exchange Imaging in IPF and cHP: A Reliability StudyIdiopathic Pulmonary Fibrosis;Hypersensitivity PneumonitisDrug: Hyperpolarized Xe129University of Kansas Medical CenterDuke University;Children's Hospital Medical Center, Cincinnati;Boehringer IngelheimNot yet recruiting18 YearsN/AAll40Phase 2NULL
14NCT03720483
(ClinicalTrials.gov)
January 202218/7/2018Inhaled NAC in Treatment of IPFPilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: N-acetyl cysteine then Placebo;Drug: Placebo then N-acetyl cysteineUniversity of Colorado, DenverNULLWithdrawn40 Years75 YearsAll0Phase 1/Phase 2United States
15EUCTR2020-001429-30-AT
(EUCTR)
29/12/202104/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
16NCT05041426
(ClinicalTrials.gov)
December 6, 202120/4/2021Letermovir for CMV Prevention After Lung TransplantationAn Open-label Pilot Protocol to Evaluate the Efficacy of Letermovir for the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Lung Transplant Recipients With Idiopathic Pulmonary FibrosisLung Transplant;CMVDrug: Letermovir;Drug: ValganciclovirFernanda P Silveira, MD, MSMerck Sharp & Dohme Corp.Recruiting18 Years100 YearsAll30Phase 2United States
17JPRN-jRCT2051210129
05/12/202105/12/2021A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE)A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE) - WA42293 Idiopathic pulmonary fibrosisRO7490677 (PRM-151) is administered intravenously at 10 mg / kg every 4 weeks for 48 weeks.Makino RyokoNULLRecruiting>= 40age old<= 85age oldBoth60Phase 3Spain;Sweden;Japan;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;South Korea;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Russian Federation;Singapore;South Africa
18NCT05134727
(ClinicalTrials.gov)
November 18, 202115/11/2021Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy ParticipantsA Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Oral AZD5055 Following Single and Multiple Ascending DosesIdiopathic Pulmonary FibrosisDrug: AZD5055;Drug: PlaceboAstraZenecaNULLRecruiting18 Years45 YearsAll104Phase 1United States
19NCT05119972
(ClinicalTrials.gov)
October 21, 20219/10/2021Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: ZSP1603;Drug: PlaceboGuangdong Raynovent Biotech Co., LtdNULLRecruiting40 YearsN/AAll36Phase 1/Phase 2China
20NCT05052229
(ClinicalTrials.gov)
October 1, 20212/9/2021Inhaled Nitric Oxide (iNO) in Idiopathic Pulmonary Fibrosis (IPF).Pulmonary Gas Exchange and Neuro-sensory Abnormalities in Patients With Idiopathic Pulmonary Fibrosis and Mild Mechanical Restriction. Implications for Dyspnea and Exercise IntoleranceIdiopathic Pulmonary FibrosisDrug: Nitric Oxide;Drug: Medical airQueen's UniversityBoehringer IngelheimNot yet recruiting40 YearsN/AAll40Early Phase 1Canada
21NCT05022771
(ClinicalTrials.gov)
October 202120/8/2021A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015A Phase 1A, First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 in Healthy VolunteersIdiopathic Pulmonary FibrosisDrug: PMG1015 Dose 1;Drug: PMG1015 Dose 2;Drug: PMG1015 Dose 3;Drug: PMG1015 Dose 4;Drug: PMG1015 Dose 5;Drug: PMG1015 Dose 6;Drug: PlaceboPulmongene Ltd.NULLNot yet recruiting18 Years60 YearsAll46Phase 1Australia
22EUCTR2020-001429-30-NO
(EUCTR)
15/09/202107/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
23NCT04986540
(ClinicalTrials.gov)
August 30, 202127/7/2021A Trial of SHR - 1906 in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 in Healthy SubjectsIdiopathic Pulmonary FibrosisDrug: SHR-1906;PlaceboGuangdong Hengrui Pharmaceutical Co., LtdNULLNot yet recruiting18 Years55 YearsAll48Phase 1NULL
24NCT04594707
(ClinicalTrials.gov)
August 30, 202115/10/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary FibrosisA Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: PRM-151Hoffmann-La RocheNULLRecruitingN/AN/AAll700Phase 3United States;Argentina;Australia;Belgium;China;Czechia;France;Israel;Italy;Mexico;Netherlands;New Zealand;Peru;Poland;Spain;Austria;Brazil;Canada;Denmark;Germany;Greece;Hong Kong;Hungary;Puerto Rico;South Africa;Sweden;Switzerland;Ukraine
25NCT04968574
(ClinicalTrials.gov)
August 26, 202129/6/2021A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: taladegib;Drug: placeboEndeavor Biomedicines, Inc.NULLRecruiting40 YearsN/AAll60Phase 2Australia;Malaysia
26NCT05032066
(ClinicalTrials.gov)
August 25, 202127/8/2021A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: HZN-825;Drug: PlaceboHorizon Therapeutics Ireland DACNULLRecruiting18 Years80 YearsAll360Phase 2United States
27NCT05007340
(ClinicalTrials.gov)
August 24, 202129/7/2021ILD-SARDs Registry and BiorepositoryInterstitial Lung Disease in Systemic Autoimmune Rheumatic Diseases (ILD-SARDs) Registry and BiorepositoryInterstitial Lung Disease;Systemic Autoimmune Disease;Rheumatic Diseases;Rheumatic Arthritis;Systemic Sclerosis;Autoimmune Myositis;Systemic Lupus Erythematosus;Usual Interstitial Pneumonia;Nonspecific Interstitial PneumoniaOther: Blood draws;Other: Other biological samples to biobank (skin, lung and muscle biopsies; bronchoalveolar lavage (BAL fluid);Other: Clinical data collection;Other: Genetic data/DNA/RNAMcGill University Health Centre/Research Institute of the McGill University Health CentreMcGill UniversityRecruiting18 YearsN/AAll252Canada
28NCT05022784
(ClinicalTrials.gov)
August 23, 202120/8/2021Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis PatientsReal-World Medication Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis PatientsIdiopathic Pulmonary FibrosisDrug: NintedanibBoehringer IngelheimNULLActive, not recruiting66 YearsN/AAll1500United States
29EUCTR2020-000791-38-DK
(EUCTR)
06/08/202111/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden;United Kingdom;Austria;Turkey;Finland;Czechia;Korea, Republic of;China;Netherlands;South Africa;Denmark;Australia;Peru;France;Italy;Switzerland;Israel;Russian Federation;Ukraine;Spain;Greece;Taiwan;Hong Kong;United States;Portugal
30NCT04996303
(ClinicalTrials.gov)
July 27, 20212/8/2021Efficacy of Steroid Pulse Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF) Admitted in EREfficacy of Steroid Pulse Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF) Admitted in ERIdiopathic Pulmonary Fibrosis With Acute ExacerbationDrug: Routine steroid administration group;Device: Steroid pulse therapy groupYonsei UniversityNULLRecruiting20 Years85 YearsAll200N/AKorea, Republic of
31NCT04888715
(ClinicalTrials.gov)
July 23, 202128/4/2021To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy VolunteersAn Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy VolunteersIdiopathic Pulmonary FibrosisDrug: DWN12088;Drug: Pirfenidone;Drug: NintedanibDaewoong Pharmaceutical Co. LTD.NULLCompleted19 Years55 YearsAll48Phase 1Korea, Republic of
32JPRN-jRCT2071210016
11/07/202128/04/2021Drug-drug interaction study of TAS-115 with lansoprazole in healthy subjectsDrug-drug interaction study of TAS-115 with lansoprazole in healthy subjects Idiopathic pulmonary fibrosisDay 1:TAS-115 will be orally administered.
Day11-Day14:Lansoprazole will be orally administered once a day.
Day 15:Lansoprazole will be orally administered and TAS-115 will be orally administered 1 hour later.
Huang JinhongNULLComplete>= 20age old< 40age oldMale14Phase 1Japan
33EUCTR2020-001429-30-DK
(EUCTR)
07/07/202112/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
34NCT04888728
(ClinicalTrials.gov)
June 30, 202128/4/2021To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy VolunteersAn Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Male VolunteersIdiopathic Pulmonary FibrosisDrug: DWN12088;Drug: Nebivolol;Drug: ParoxetineDaewoong Pharmaceutical Co. LTD.NULLCompleted20 Years55 YearsMale24Phase 1Korea, Republic of
35NCT04965298
(ClinicalTrials.gov)
June 16, 20217/7/2021Treating People With Idiopathic Pulmonary Fibrosis With the Addition of LansoprazoleThe Effectiveness and Risks of Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole: a Randomised Placebo-controlled Multi-centre Clinical TrialIdiopathic Pulmonary FibrosisDrug: Lansoprazole;Other: Matched placeboNorfolk and Norwich University Hospitals NHS Foundation TrustNorwich Clinical Trials UnitRecruiting40 YearsN/AAll298Phase 3United Kingdom
36NCT04708782
(ClinicalTrials.gov)
June 1, 202112/1/2021Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Interstitial Lung DiseaseDrug: Placebo;Drug: Inhaled Treprostinil;Device: Treprostinil Ultrasonic NebulizerUnited TherapeuticsNULLRecruiting40 YearsN/AAll396Phase 3United States
37EUCTR2020-000791-38-DE
(EUCTR)
28/05/202102/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
38EUCTR2020-001429-30-DE
(EUCTR)
26/05/202103/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677/F01-01
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677/F01-02
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677/F01-03
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
39EUCTR2020-000791-38-NO
(EUCTR)
25/05/202108/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Korea, Republic of;Czechia;Finland;Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
40NCT04931147
(ClinicalTrials.gov)
May 13, 20214/6/2021A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy VolunteersA Randomised, Double-blind, Placebo-controlled, SAD/MAD First-in-human, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RXC007 Including Evaluation of Drug-Drug Interaction and Food Effect in Male ParticipantsFibrosis;Inflammation;Idiopathic Pulmonary Fibrosis;Non-alcoholic Steatohepatitis;Liver Diseases;Kidney DiseasesDrug: RXC007;Drug: RXC007 Matching PlaceboRedx Pharma PlcSimbec ResearchRecruiting18 Years55 YearsMale80Phase 1United Kingdom
41EUCTR2020-001429-30-NL
(EUCTR)
07/05/202101/02/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
42EUCTR2020-001429-30-SE
(EUCTR)
07/05/202104/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677/F01-01
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677/F01-02
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677/F01-03
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
43EUCTR2020-000697-22-IE
(EUCTR)
04/05/202102/12/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
44EUCTR2020-000791-38-NL
(EUCTR)
29/04/202121/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
45EUCTR2020-005103-39-PL
(EUCTR)
24/04/202124/03/2021Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary FibrosisAccess to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pirfenidone Solution for Inhalation
Product Code: AP01
INN or Proposed INN: PIRFENIDONE
Other descriptive name: NA
Avalyn Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czechia;Czech Republic;Poland;Australia;Netherlands;United Kingdom;New Zealand
46EUCTR2020-005103-39-CZ
(EUCTR)
16/04/202122/12/2020Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary FibrosisAccess to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pirfenidone Solution for Inhalation
Product Code: AP01
INN or Proposed INN: PIRFENIDONE
Other descriptive name: NA
Avalyn Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czechia;Czech Republic;Poland;Australia;Netherlands;United Kingdom;New Zealand
47EUCTR2020-000791-38-SE
(EUCTR)
14/04/202127/11/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
48EUCTR2019-004167-45-CZ
(EUCTR)
12/04/202118/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
49EUCTR2020-001429-30-PT
(EUCTR)
09/04/202114/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
50NCT04739150
(ClinicalTrials.gov)
March 29, 20211/2/2021An Expanded Access Program in Belgium to Provide Nintedanib to People With Lung Diseases Called Non-IPF ILDs Who Have no Alternative Treatment OptionsMedical Need Program With Ofev® (Nintedanib) for the Treatment of Adult Patients With Non-IPF (Idiopathic Pulmonary Fibrosis) Chronic Fibrosing Interstitial Lung Diseases (ILDs) With a Progressive Phenotype (PF-ILD's)Lung Diseases, InterstitialDrug: nintedanibBoehringer IngelheimNULLAvailable18 YearsN/AAllBelgium
51NCT04767815
(ClinicalTrials.gov)
March 22, 202115/2/2021To Evaluate Food Effect on the PK and Safety After Oral DWN12088 Administration in Healthy Adult VolunteersA Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics and Safety After Oral DWN12088 Administration in Healthy Adult VolunteersIdiopathic Pulmonary FibrosisDrug: Diet A group;Drug: Diet B group;Drug: Diet C groupDaewoong Pharmaceutical Co. LTD.NULLCompleted19 Years55 YearsAll36Phase 1Korea, Republic of
52EUCTR2020-000791-38-PT
(EUCTR)
19/03/202117/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
53NCT04552899
(ClinicalTrials.gov)
March 19, 202114/9/2020A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary FibrosisA Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: PRM-151;Drug: PlaceboHoffmann-La RocheNULLRecruiting40 Years85 YearsAll658Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Spain;Taiwan;Turkey;Ukraine;Brazil;Finland;Puerto Rico;Russian Federation;Singapore;South Africa;Sweden;Switzerland;United Kingdom
54EUCTR2020-000791-38-FI
(EUCTR)
16/03/202109/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
55EUCTR2020-001429-30-FR
(EUCTR)
15/03/202127/11/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden
56EUCTR2020-001429-30-GR
(EUCTR)
18/02/202107/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden
57EUCTR2020-000791-38-GR
(EUCTR)
18/02/202107/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden
58EUCTR2019-002709-23-NL
(EUCTR)
16/02/202106/08/2020A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not Available
Other descriptive name: PLN-74809-020
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
112Phase 2France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;New Zealand;Italy;Korea, Republic of
59EUCTR2020-001429-30-FI
(EUCTR)
16/02/202104/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden
60NCT04643769
(ClinicalTrials.gov)
February 9, 202111/11/2020Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Phase 1b Double-Blind, Placebo-Controlled, Ascending Dose Trial: ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: ORIN1001;Drug: PlaceboOrinove, Inc.Vanderbilt UniversityRecruiting40 Years80 YearsAll24Phase 1United States
61EUCTR2020-001429-30-HU
(EUCTR)
05/02/202109/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden
62EUCTR2020-000791-38-HU
(EUCTR)
05/02/202104/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;New Zealand;Sweden;Norway;Germany;Singapore;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Turkey;Finland;Czechia;Korea, Republic of;China;Netherlands;South Africa;Peru;Australia;Denmark;France
63EUCTR2020-001429-30-PL
(EUCTR)
28/01/202119/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677/ F01-02
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677/F01-03
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
64JPRN-jRCT2031210008
27/01/202102/04/2021A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareA Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary FibrosisThis clinical Phase 3 study is a randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the efficacy and safety of two doses (200 mg q.d. and 600 mg q.d.) of orally administered GLPG1690 in addition to local standard of care for at least 52 weeks in adult subjects with a centrally confirmed diagnosis of IPF. Local standard of care for IPF is defined as receiving either pirfenidone or nintedanib at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months. A total of approximately 750 subjects with confirmed diagnosis of IPF will be randomized, 250 subjects in each treatment group (GLPG1690 600 mg q.d., GLPG1690200 mg q.d., or matching placebo).Kayamori TakefumiNULLNot Recruiting>= 40age oldNot applicableBoth49Phase 3Japan;USA;Denmark;Peru;Australia;Germany;Taiwan;Belgium;Greece;Brazil;Spain;Chile;United Kingdom;Czech Republic;Turkey
65EUCTR2020-000791-38-PL
(EUCTR)
22/01/202119/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
66EUCTR2020-001429-30-CZ
(EUCTR)
20/01/202102/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden
67EUCTR2020-000791-38-CZ
(EUCTR)
20/01/202130/11/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden
68JPRN-jRCTs051200109
18/01/202115/01/2021DREAM studyA multicenter, open-label, prospective study of durvalumab, etoposide, and carboplatin for unresectable small cell lung cancer with mild idiopathic interstitial pneumonia - DREAM study Small cell lung cancerPatients will receive etoposide (<75 years old: 100mg/m2; >=75 years old: 80mg/m2; intravenously on day 1-3), carboplatin (area under the curve 5 mg/mL intravenously on day 1), and durvalumab (1500mg/body intravenously on day1) every three weeks for four cycles. Thereafter, patients will continue to receive durvalumab monotherapy (1500mg/body intravenously on day 1 every three weeks), until relapse, or unacceptable toxicity.Fujimoto DaichiNULLRecruiting>= 20age oldNot applicableBoth22N/AJapan
69NCT04525547
(ClinicalTrials.gov)
January 13, 202121/8/2020Safety and Effectiveness of Nintedanib in Korean PatientsA Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean PatientsIdiopathic Pulmonary FibrosisDrug: NintedanibBoehringer IngelheimNULLRecruitingN/AN/AAll3000Korea, Republic of
70EUCTR2019-002709-23-IT
(EUCTR)
29/12/202024/05/2021A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN 74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) - INTEGRIS-IPF idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: PLN-74809
Product Code: [PLN-74809]
Other descriptive name: PLN-74809-000
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2France;United States;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
71NCT04614441
(ClinicalTrials.gov)
December 25, 202029/10/2020NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of People With Certain Types of Lung Disease (PF-ILD, SSc-ILD, IPF) Who Start Treatment With Nintedanib.Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel TherapyIdiopathic Pulmonary FibrosisDrug: OFEV®Boehringer IngelheimNULLRecruiting20 YearsN/AAll500Taiwan
72EUCTR2020-000697-22-NL
(EUCTR)
24/12/202004/06/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
73EUCTR2020-000791-38-IT
(EUCTR)
21/12/202015/06/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS - - Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: [RO7490677]
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
74EUCTR2020-001429-30-IT
(EUCTR)
21/12/202014/06/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) - - Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: [RO7490677]
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
75EUCTR2019-002709-23-DE
(EUCTR)
18/12/202031/01/2020A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 inparticipants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not Available
Other descriptive name: PLN-74809-020
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
112Phase 2United States;France;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy;Korea, Republic of
76NCT04300920
(ClinicalTrials.gov)
December 17, 20206/3/2020Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) TrialProspective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) TrialIdiopathic Pulmonary FibrosisDrug: N-acetyl cysteine;Drug: PlaceboWeill Medical College of Cornell UniversityUniversity of Virginia;University of Michigan;Pulmonary Fibrosis Foundation;University of Washington;National Heart, Lung, and Blood Institute (NHLBI);Three Lakes FoundationRecruiting40 YearsN/AAll200Phase 3United States
77EUCTR2019-004167-45-GR
(EUCTR)
17/12/202003/12/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
NULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
78NCT04429516
(ClinicalTrials.gov)
December 17, 202012/3/2020Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis CoughPAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis CoughIdiopathic Pulmonary FibrosisDrug: Morphine Sulfate;Drug: Placebo oral tabletRoyal Brompton & Harefield NHS Foundation TrustNULLRecruiting40 Years90 YearsAll44Phase 3United Kingdom
79EUCTR2019-003992-21-IT
(EUCTR)
15/12/202030/08/2021A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants with Lung FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis Pulmonary Fibrosis
MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BMS-986278
Product Code: [BMS-986278]
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Product Name: BMS-986278
Product Code: [BMS-986278]
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Germany;Japan;Korea, Republic of
80NCT04362644
(ClinicalTrials.gov)
December 8, 20202/3/2020Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary FibrosisMolecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714University of Alabama at BirminghamNULLRecruiting40 Years85 YearsAll10Phase 1United States
81NCT04533022
(ClinicalTrials.gov)
November 13, 202026/8/2020Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPFA Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: C21Vicore Pharma ABOrphan ReachRecruiting40 YearsN/AAll60Phase 2India;Russian Federation;Ukraine;United Kingdom
82NCT04598919
(ClinicalTrials.gov)
November 12, 202015/9/2020Saracatinib in the Treatment of Idiopathic Pulmonary FibrosisUse of the Src Family Kinase Inhibitor Saracatinib in the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: Saracatinab;Drug: PlaceboNational Jewish HealthYale University;Icahn School of Medicine at Mount Sinai;AstraZeneca;National Center for Advancing Translational Science (NCATS)Recruiting40 YearsN/AAll100Phase 1/Phase 2United States
83EUCTR2019-002709-23-GB
(EUCTR)
06/11/202024/01/2020A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not Available
Other descriptive name: PLN-74809-000
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not available
Other descriptive name: PLN-74809-000
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not Available
Other descriptive name: PLN-74809-000
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;France;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom
84EUCTR2019-004167-45-SK
(EUCTR)
02/11/202011/08/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
85EUCTR2019-004167-45-AT
(EUCTR)
23/10/202006/07/2020A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
86NCT04262167
(ClinicalTrials.gov)
October 22, 20206/2/2020Human Autologous Lung Stem Cell Transplant for Idiopathic Pulmonary FibrosisA Phase I, Randomized Study of the Safety and Efficacy of Intravenous Delivery of Lung Spheroid Stem Cells (LSCs) in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: Lung Spheroid Stem Cells 100 million;Biological: Lung Spheroid Stem Cells 200 millionUniversity of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Recruiting50 Years80 YearsAll24Phase 1United States
87NCT04589260
(ClinicalTrials.gov)
October 15, 20208/10/2020TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary FibrosisA Ph 1, Rndmzd, Dbl-Blinded, Pbo-Controlled, 3-Part Study to Eval the Safety, Tolerability, PK, and PD of TD-1058 Admin by Inhalation of Single (A) and Multiple (B) Ascending Doses in Healthy Subjs and Subjs With IPF (C)Idiopathic Pulmonary Fibrosis (IPF)Drug: TD-1058;Drug: PlaceboTheravance BiopharmaNULLRecruiting18 YearsN/AAll96Phase 1United Kingdom
88EUCTR2020-000697-22-DK
(EUCTR)
13/10/202014/08/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Denmark;Peru;Georgia;Netherlands;Germany
89EUCTR2020-000697-22-DE
(EUCTR)
13/10/202005/08/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
90NCT04419558
(ClinicalTrials.gov)
September 30, 20203/6/2020Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: PlaceboFibroGenNULLRecruiting40 Years85 YearsAll340Phase 3United States;Brazil;Colombia;Czechia;Denmark;Dominican Republic;France;Georgia;Germany;Hungary;Ireland;Italy;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Serbia;Spain;Switzerland;Ukraine;United Kingdom
91NCT04497831
(ClinicalTrials.gov)
September 21, 202025/7/2020Morphine for Dyspnea in Pulmonary FibrosisDetermining the Effectiveness of Nebulized Morphine in Treating Dyspnea in Advanced Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: Morphine hydrochloride;Drug: PlaceboMedical University of GdanskNULLNot yet recruiting18 YearsN/AAll20Phase 3NULL
92NCT04312594
(ClinicalTrials.gov)
September 8, 202027/2/2020Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary FibrosisA Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Trial of Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets;Drug: Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets;Drug: Placebo oral tablet and Acetylcysteine Effervescent TabletsSuzhou Zelgen Biopharmaceuticals Co.,LtdNULLRecruiting50 YearsN/AAll90Phase 2China
93NCT04534478
(ClinicalTrials.gov)
September 7, 202031/8/2020Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19Randomized, Open, Parallel, Single-center, Non-inferiority Clinical Trial, With an Active Control Group, Comparing Two Oral Prednisone Regimens With the Aim of Optimizing the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 InfectionCOVID-19 PneumoniaDrug: PrednisoneHospital Universitari Vall d'Hebron Research InstituteNULLNot yet recruiting18 YearsN/AAll120Phase 4NULL
94NCT03865927
(ClinicalTrials.gov)
September 7, 20201/3/2019GKT137831 in IPF Patients With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisOther: Placebo Oral Tablet;Drug: GKT137831University of Alabama at BirminghamNULLRecruiting40 Years85 YearsAll60Phase 2United States
95NCT04187690
(ClinicalTrials.gov)
September 1, 20203/12/2019Jin-shui Huan-xian Granule in the Treatment of IPFEfficacy and Safety of Jin-shui Huan-xian Granule in the Treatment of IPFIdiopathic Pulmonary FibrosisDrug: Jin-shui Huan-xian granule;Drug: Jin-shui Huan-xian granule placeboHenan University of Traditional Chinese MedicineNULLRecruiting40 Years85 YearsAll312N/AChina
96EUCTR2019-004167-45-DK
(EUCTR)
27/08/202012/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
97EUCTR2019-004167-45-PL
(EUCTR)
24/08/202014/07/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Germany;Japan;Poland;Argentina;Canada;Mexico;Czech Republic;Hungary;United Kingdom;Austria;Finland;Czechia;Korea, Republic of;China;Netherlands;Australia;Denmark;France;Italy;Russian Federation;Chile;Ukraine;Spain;Greece;Slovakia;United States
98EUCTR2019-004167-45-GB
(EUCTR)
19/08/202024/06/2020A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
99EUCTR2019-004167-45-HU
(EUCTR)
17/08/202024/06/2020A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
100EUCTR2019-003992-21-DE
(EUCTR)
06/08/202027/05/2020A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants with Lung FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis Pulmonary Fibrosis
MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BMS-986278
Product Code: BMS-986278
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Product Name: BMS-986278
Product Code: BMS-986278
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Germany;Japan;Korea, Republic of
101NCT04071769
(ClinicalTrials.gov)
August 3, 20209/8/2019Genentech Xenon MRI Idiopathic Pulmonary FibrosisUsing Xenon MRI to Evaluate the Efficacy of Therapies for Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) TreatmentDuke UniversityNULLRecruiting18 YearsN/AAll20Phase 2United States
102EUCTR2019-004167-45-DE
(EUCTR)
30/07/202022/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
103NCT04318704
(ClinicalTrials.gov)
July 29, 202020/3/2020Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated CoughAn Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated CoughIdiopathic Pulmonary FibrosisDrug: IfenprodilAlgernon PharmaceuticalsNULLActive, not recruitingN/A85 YearsAll20Phase 2Australia;New Zealand
104EUCTR2020-000697-22-IT
(EUCTR)
29/07/202021/01/2021A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). - Zephyrus II Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: [FG-3019]
INN or Proposed INN: PAMREVLUMAB
FIBROGENNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Poland;Brazil;Belgium;Dominican Republic;Denmark;Peru;Georgia;Bulgaria;Norway;Netherlands;Germany
105NCT04419506
(ClinicalTrials.gov)
July 28, 20204/6/2020A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken OrallyIdiopathic Pulmonary FibrosisDrug: BI 1015550;Drug: PlaceboBoehringer IngelheimNULLCompleted40 YearsN/AAll147Phase 2United States;Argentina;Australia;Austria;Canada;Chile;China;Czechia;Denmark;Finland;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
106EUCTR2019-004998-34-GB
(EUCTR)
16/07/202004/02/2020A clinical study to investigate the safety and effects of a new drug called BLD-2660 in patients with Idiopathic Pulmonary FibrosisA Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis - B-2660-203 Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BLD-2660
Product Code: BLD-2660
INN or Proposed INN: None
Other descriptive name: BLD-2660
Blade Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United Kingdom
107NCT04512170
(ClinicalTrials.gov)
July 13, 20207/8/2020Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female SubjectsA Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Randomized, Open-label,Crossover, Food Effect Study of HEC585 in Healthy Chinese SubjectsIdiopathic Pulmonary FibrosisDrug: HEC585;Drug: placeboSunshine Lake Pharma Co., Ltd.NULLCompleted18 Years45 YearsAll72Phase 1China
108EUCTR2019-004167-45-NL
(EUCTR)
09/07/202012/05/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
109EUCTR2019-004167-45-IT
(EUCTR)
09/07/202017/06/2021A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. - - Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: -
Product Code: [BI 1015550]
Other descriptive name: BI 1015550
Product Name: -
Product Code: [BI 1015550]
Other descriptive name: BI 1015550
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Czechia;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
110EUCTR2020-000697-22-HU
(EUCTR)
08/07/202022/05/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Poland;Belgium;Brazil;Dominican Republic;Peru;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
111EUCTR2020-000822-24-GB
(EUCTR)
06/07/202003/04/2020To investigate the safety, effectiveness and fate of study drug C21 in people with chronic scarring lung disease characterised by a progressive and irreversible decline in lung function.A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects with Idiopathic Pulmonary Fibrosis - C21 in IPF Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: C21
INN or Proposed INN: C21
Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt
Vicore Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Ukraine;United Kingdom
112EUCTR2019-003992-21-BE
(EUCTR)
03/07/202004/05/2020A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis Pulmonary Fibrosis
MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BMS-986278
Product Code: BMS-986278
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Product Name: BMS-986278
Product Code: BMS-986278
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Japan;Korea, Republic of
113EUCTR2020-000041-14-GB
(EUCTR)
19/06/202008/07/2020Treating people with Idiopathic Pulmonary fibrosis with the Addition of LansoprazoleThe effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): a randomised placebo-controlled multi-centre clinical trial - TIPAL Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Lansoprazole
Product Name: Lansoprazole
INN or Proposed INN: lansoprazole
Other descriptive name: N/A
Norfolk and Norwich University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
298Phase 3United Kingdom
114NCT03939520
(ClinicalTrials.gov)
June 11, 20203/5/2019Management of Progressive Disease in Idiopathic Pulmonary FibrosisPragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized TrialProgressive Idiopathic Pulmonary FibrosisDrug: pirfenidone and nintedanib;Drug: pirfenidone or nintedanibHospices Civils de LyonNULLRecruiting50 YearsN/AAll378Phase 4France
115EUCTR2018-002664-73-IE
(EUCTR)
25/05/202020/12/2018Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks Patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: GB0139 (previously known as TD139)
Product Code: GB0139 (previously known as TD139)
INN or Proposed INN: GB0139 (previously known as TD139)
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2Germany;Georgia;Australia;Poland;Belgium;Canada;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;United States
116EUCTR2019-003571-19-GB
(EUCTR)
21/05/202027/02/2020A multicentre, double blind, placebo controlled, crossover trial of morphine sulphate sulfate for the treatment of PulmonAry Fibrosis Cough (PAciFy Cough Trial)PAciFy Cough: A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough - PACIFY Cough Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Morphine Sulfate
Product Name: Morphine Sulfate
INN or Proposed INN: morphine sulfate
Royal Brompton and Harefield NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 3United Kingdom
117EUCTR2019-004167-45-FI
(EUCTR)
18/05/202015/04/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
118ChiCTR2000031386
2020-04-012020-03-29The impact of NAC treatment in IPF patients in mainland China: a retrospective studyThe impact of NAC treatment in IPF patients in mainland China: a retrospective study idiopathic pulmonary fibrosisStudy group:acetylcysteine 0.6 tid po.;control group:did not take NAC or other antifibrotic drugs;Shanghai Pulmonary Hospital, Tongji University School of MedicineNULLRecruitingBothStudy group:348;control group:174;China
119NCT04326036
(ClinicalTrials.gov)
March 25, 202026/3/2020Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 InfectionUse of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) InfectionPulmonary Alveolar Proteinosis;COPD;Idiopathic Pulmonary Fibrosis;Viral Pneumonia;Coronavirus Infection;Interstitial Lung DiseaseProcedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF);Device: Centricyte 1000;Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution;Drug: Liberase Enzyme (Roche);Drug: Sterile Normal Saline for Intravenous UseBlack Tie Medical, Inc.Robert W. Alexander, MDEnrolling by invitation18 Years90 YearsAll10Early Phase 1United States
120NCT04396756
(ClinicalTrials.gov)
March 3, 20206/5/2020Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)Idiopathic Pulmonary FibrosisDrug: PLN-74809;Drug: PlaceboPliant Therapeutics, Inc.NULLRecruiting40 YearsN/AAll84Phase 2United States;Australia;Belgium;Canada;Italy;Netherlands;New Zealand
121ChiCTR2000030400
2020-03-012020-03-01Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial PneumoniaEffects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia Interstitial pneumoniaCase series:Tetrandrine;The First People's Hospital of YanchengNULLRecruiting3678BothCase series:41;China
122EUCTR2019-004326-19-FR
(EUCTR)
27/01/202013/11/2019Management of Progressive Disease in Idiopathic Pulmonary Fibrosis Pragmatic management of progressive disease in idiopathic pulmonary fibrosis: a randomized trial - PROGRESSION-IPF Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: pirfenidone
INN or Proposed INN: PIRFENIDONE
Trade Name: nintedanib
Other descriptive name: NINTEDANIB
Hospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
378 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
123NCT04233814
(ClinicalTrials.gov)
January 20, 202012/1/2020Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult SubjectsA Randomized, Double-Blind, Placebo-Controlled, Ph 1a, First-in-Man, Single Ascending Dose & Multiple Ascending Dose Safety, Tolerability and PK Study of a Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Healthy Adult SubjectsIdiopathic Pulmonary FibrosisDrug: Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03);Drug: PlaceboLung Therapeutics, IncNULLCompleted18 Years55 YearsAll71Phase 1United Kingdom
124ChiCTR2000037602
2020-01-012020-08-29Clinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosisClinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosis Interstitial lung disease1:Dextromethorphan+Pirfenidone;2:Pirfenidone;Tianjin Medical University General HospitalNULLRecruiting1875Both1:100;2:100;Phase 4China
125NCT04244825
(ClinicalTrials.gov)
December 15, 20193/1/2020Safety, Pharmacodynamics, and Pharmacokinetics of Orally Administered BLD-2660 in Subjects With IPFA Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BLD-2660;Drug: Control: PlaceboBlade TherapeuticsNULLWithdrawn45 YearsN/AAll0Phase 2United Kingdom
126NCT04720443
(ClinicalTrials.gov)
November 22, 201930/12/2020A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal SubjectsA Phase 1, Two-Part Study of NIP292 Tablets in Healthy Adult Subjects: Part 1 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses; Part 2 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses.Idiopathic Pulmonary FibrosisDrug: NIP292 tablet;Drug: NIP292 tabletsThe National Institutes of Pharmaceutical R&D Co. Ltd, ChinaNULLRecruiting18 Years55 YearsAll72Phase 1United States
127ChiCTR1900027121
2019-10-282019-11-01The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trialThe efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial nonspecific interstitial pneumonia (NSIP)Group-1:Mycophenolate mofetil dispersible tablets 2 g /d; Steroid 0.75 mg/kg/d;Group-2:Tacrolimus capsule, 3mg/d, Steroid 0.75 mg/kg/d;Group-3:Cyclophosphamide 1-2mg/kg/d, Steroid 0.75 mg/kg/d;Control group:Steroid from 0.75 mg/kg/d to 15 mg/d.;Peking Union Medical College HospitalNULLRecruiting1875BothGroup-1:30;Group-2:30;Group-3:30;Control group:30;Phase 4China
128JPRN-jRCTs031190119
28/10/201918/10/2019A phase II Study of CBDCA + ETP + Nintedanib for SCLC with IPFA Phase II Study of Carboplatin and Etoposide Plus Nintedanib for Unresectable Limited/Extensive Disease Small Cell Lung Cancer with Idiopathic Pulmonary Fibrosis - TORG1835 / NEXT-SHIP Unresectable limited or extensive disease small cell lung cancer with idiopathic pulmonary fibrosisThe patients receive carboplatin(area under the curve 5 mg/mL, intravenously, day 1), etoposide (<75 years old:100mg/m2:>=75years old:80mg/m2;intravenously,days 1-3), and nintedanib (150mg twice a day, orally). The patients receive combination chemotherapy every3 weeks for 4 cycles until disease progression or unacceptable toxicity occurs. After completion or discontinuation of carboplatin plus etoposide, the patients continue nintedanib until the discontinuation criteria are satisfied.IKEDA SatoshiOGURA Takashi;Thoracic Oncology Research GroupRecruiting>= 20age oldNot applicableBoth33Phase 2Japan
129EUCTR2018-002664-73-GB
(EUCTR)
24/09/201922/01/2019Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2United States;France;Canada;Spain;Poland;Belgium;Ireland;Israel;Germany;Italy;United Kingdom
130NCT04072315
(ClinicalTrials.gov)
September 9, 201923/8/2019Phase 2a Evaluation of PLN-74809 on avß6 Receptor Occupancy Using PET Imaging in Participants With IPF/A Phase 2a Evaluation of PLN-74809 on avß6 Receptor Occupancy Using PET Imaging in Participants With IPFIdiopathic Pulmonary FibrosisDrug: PLN-74809;Radiation: Knottin tracerPliant Therapeutics, Inc.Stanford UniversityRecruiting40 YearsN/AAll12Phase 2United States
131JPRN-jRCTs031190084
05/09/201927/08/2019TORG1936 / AMBITIOUS studyA phase II study of Atezolizumab for advanced / recurrent Non-Small Cell Lung Cancer with Idiopathic Interstitial Pneumonias - TORG1936 / AMBITIOUS study Advanced / recurrent Non-small cell lung cancer with idiopathic interstitial pneumoniaAtezolizumab 1200mg, every 3 weeksKATO TerufumiIKEDA SatoshiSuspended>= 20age oldNot applicableBoth38Phase 2Japan
132NCT04030026
(ClinicalTrials.gov)
August 8, 201911/7/2019A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of CoughPhase 2, Double-blind, Randomized, Placebo-controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis (IPF) With Nalbuphine ER Tablets for the Treatment of CoughNalbuphine;Idiopathic Pulmonary Fibrosis;CoughDrug: Nalbuphine ER;Drug: Placebo oral tabletTrevi TherapeuticsParexelActive, not recruiting18 Years80 YearsAll60Phase 2United Kingdom
133EUCTR2018-002664-73-IT
(EUCTR)
17/07/201915/01/2021Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks - - patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: TD139
Product Code: [TD139]
INN or Proposed INN: TD139
Other descriptive name: DEX284
Product Name: TD139
Product Code: [TD139]
INN or Proposed INN: TD139
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2France;United States;Canada;Spain;Poland;Belgium;Ireland;Israel;Germany;United Kingdom;Italy
134EUCTR2018-002664-73-FR
(EUCTR)
09/07/201922/01/2019Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Poland;Belgium;Spain;Israel;Germany;Italy;United Kingdom
135EUCTR2018-002664-73-PL
(EUCTR)
09/07/201914/03/2019Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: GB0139 (previously known as TD139)
Product Code: GB0139 (previously known as TD139)
INN or Proposed INN: GB0139 (previously known as TD139)
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
141Phase 2United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Poland;Belgium;Australia;Georgia;Germany
136NCT03562416
(ClinicalTrials.gov)
July 5, 20197/5/2018Continuation of Nintedanib After Single Lung Transplantation in IPF SubjectsNintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled TrialIdiopathic Pulmonary Fibrosis;Lung Transplant; ComplicationsDrug: Nintedanib;Drug: Placebo Oral TabletTemple UniversityBoehringer IngelheimRecruiting35 Years70 YearsAll20Phase 2United States
137EUCTR2018-004447-23-DE
(EUCTR)
04/07/201907/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Netherlands;Germany;United Kingdom;Italy
138NCT03955146
(ClinicalTrials.gov)
June 27, 201916/5/2019Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary FibrosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: PlaceboFibroGenNULLRecruiting40 Years85 YearsAll340Phase 3United States;Argentina;Australia;Chile;China;Hong Kong;Japan;Korea, Republic of;Russian Federation;Taiwan;Czechia;France;Germany;Hungary;Italy;Lebanon;Netherlands;Peru;Spain
139EUCTR2018-004744-31-GB
(EUCTR)
24/06/201905/03/2019Efficacy and Safety Study: Nalbuphine ER Tablets for the Treatment of Cough in Idiopathic Pulmonary FibrosisA Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis With Nalbuphine ER Tablets for the Treatment of Cough - CANAL Treatment of Cough in Idiopathic Pulmonary Fibrosis;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]Product Name: Nalbuphine Extended-Realease (ER) Tablets
Product Code: TR0311
INN or Proposed INN: Nalbuphine
Other descriptive name: NALBUPHINE HYDROCHLORIDE
Product Name: Nalbuphine Extended-Release (ER) Tablets
Product Code: TR0311
INN or Proposed INN: Nalbuphine
Other descriptive name: NALBUPHINE HYDROCHLORIDE
Product Name: Nalbuphine Extended-Release (ER) Tablets
Product Code: TR0311
INN or Proposed INN: Nalbuphine
Other descriptive name: NALBUPHINE HYDROCHLORIDE
Product Name: Nalbuphine Extended-Release (ER) Tablets
Product Code: TR0311
INN or Proposed INN: Nalbuphine
Other descriptive name: NALBUPHINE HYDROCHLORIDE
Trevi Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United Kingdom
140EUCTR2018-004447-23-IT
(EUCTR)
18/06/201910/11/2020Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
INN or Proposed INN: cromoglicato disodico
Other descriptive name: SODIUM CROMOGLICATE
Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
INN or Proposed INN: cromoglicato disodico
Other descriptive name: SODIUM CROMOGLICATE
Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
INN or Proposed INN: cromoglicato disodico
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences, GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czechia;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
141EUCTR2018-001405-87-BE
(EUCTR)
27/05/201928/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
142EUCTR2018-004447-23-GB
(EUCTR)
20/05/201915/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial RESPIVANT RVT1601-cc-04 Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom
143EUCTR2018-004447-23-CZ
(EUCTR)
15/05/201914/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
144NCT03981094
(ClinicalTrials.gov)
May 10, 201921/5/2019A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy ParticipantsAn Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy ParticipantsIdiopathic Pulmonary Fibrosis (IPF)Drug: BMS-986278;Drug: PirfenidoneBristol-Myers SquibbNULLCompleted21 Years65 YearsAll22Phase 1United States
145EUCTR2018-004447-23-BE
(EUCTR)
02/05/201901/04/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
146EUCTR2017-003158-18-DE
(EUCTR)
30/04/201921/06/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - SPIRIT mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot Recruiting Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
147EUCTR2018-004447-23-NL
(EUCTR)
16/04/201907/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czechia;Czech Republic;Canada;Belgium;Turkey;Australia;Germany;Netherlands;United Kingdom;Italy;New Zealand
148NCT03949530
(ClinicalTrials.gov)
April 16, 20196/5/2019A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary FibrosisIDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF)Healthy Volunteers;Idiopathic Pulmonary FibrosisDrug: IDL-2965 Oral Capsule;Drug: PlacebosIndalo Therapeutics, Inc.NULLTerminated18 Years60 YearsAll6Phase 1United Kingdom
149EUCTR2018-002664-73-ES
(EUCTR)
08/04/201912/04/2019Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Poland;Belgium;Spain;Ireland;Israel;Germany;Italy;United Kingdom
150EUCTR2018-001406-29-NL
(EUCTR)
03/04/201906/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
151EUCTR2018-001405-87-GB
(EUCTR)
29/03/201905/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Germany;Peru;Denmark;Australia;Brazil;Belgium;Czech Republic;United Kingdom;Chile;Turkey;Spain;Finland;Greece;Taiwan;Czechia;United States
152NCT03864328
(ClinicalTrials.gov)
March 29, 20192/3/2019A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPFRandomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC TrialPersistent Cough in IPF;Chronic Cough;IPFDrug: RVT-1601;Drug: PlaceboRespivant Sciences GmbHRespivant Sciences Inc.Terminated40 Years89 YearsAll108Phase 2United States;Australia;Belgium;Canada;Czechia;Germany;Italy;Netherlands;New Zealand;Turkey;United Kingdom
153EUCTR2018-001405-87-DE
(EUCTR)
21/03/201926/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
154EUCTR2017-004302-18-FI
(EUCTR)
05/03/201904/09/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
155NCT04564664
(ClinicalTrials.gov)
March 1, 201914/9/2020High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary FibrosisHigh-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical TrialIdiopathic Pulmonary FibrosisDrug: OxygenParc de Salut MarHospitales Universitarios Virgen del RocíoCompleted18 Years85 YearsAll10N/ASpain
156NCT03710824
(ClinicalTrials.gov)
February 28, 201916/10/2018Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With NintedanibInvestigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With NintedanibIdiopathic Pulmonary FibrosisDrug: NintedanibBoehringer IngelheimNULLActive, not recruiting40 YearsN/AAll180Greece
157NCT03650075
(ClinicalTrials.gov)
February 25, 201920/8/2018To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy VolunteersA Phase I Study to Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its Pharmacokinetic Profile in Healthy VolunteersIdiopathic Pulmonary Fibrosis (IPF)Drug: MG-S-2525Metagone Biotech Inc.NULLCompleted20 YearsN/AAll81Phase 1Taiwan
158EUCTR2018-001405-87-GR
(EUCTR)
21/02/201922/01/2019A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
159NCT03832946
(ClinicalTrials.gov)
February 19, 20194/2/2019A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 WeeksIdiopathic Pulmonary Fibrosis (IPF)Drug: GB0139;Drug: PlaceboGalecto Biotech ABSyneos Health;bioRASI, LLCRecruiting40 YearsN/AAll500Phase 2United States;Australia;Belgium;Canada;France;Georgia;Germany;Ireland;Israel;Italy;Poland;Spain;Ukraine;United Kingdom
160EUCTR2017-003158-18-PL
(EUCTR)
18/02/201930/11/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
161NCT03830125
(ClinicalTrials.gov)
February 13, 201931/1/2019Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy SubjectsA Phase 1, 2-Stage, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 Following Single and Multiple Ascending Doses in Healthy Adult SubjectsIdiopathic Pulmonary FibrosisDrug: BBT-877, Single dose;Drug: Placebo group;Drug: BBT-877, Multiple dosesBridge Biotherapeutics, Inc.KCRN Research, LLCCompleted19 Years55 YearsAll88Phase 1United States
162NCT03958071
(ClinicalTrials.gov)
February 1, 201920/5/2019A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are TakingCharacteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the USIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: Pirfenidone;Other: Untreated CohortBoehringer IngelheimNULLCompleted40 YearsN/AAll13264United States
163EUCTR2018-001406-29-FR
(EUCTR)
28/01/201929/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;South Africa;Germany;Netherlands;New Zealand;Korea, Republic of
164EUCTR2018-001405-87-CZ
(EUCTR)
23/01/201906/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
165EUCTR2018-001406-29-HU
(EUCTR)
17/01/201904/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
166EUCTR2017-004302-18-HR
(EUCTR)
14/01/201916/05/2019A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Sweden;Bulgaria;Croatia;Romania;Oman;Ukraine;Finland;Slovakia;Egypt;France
167EUCTR2018-001406-29-PL
(EUCTR)
21/12/201817/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
168EUCTR2018-001405-87-DK
(EUCTR)
20/12/201822/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Australia;Peru;Germany
169EUCTR2018-001406-29-IT
(EUCTR)
13/12/201820/01/2021A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis - - Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: [G451990]
Product Name: GLPG1690
Product Code: [G451990]
GALAPAGOS NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Korea, Republic of;New Zealand;Germany;Netherlands;South Africa;Brazil;Poland;Argentina;Canada;Mexico
170EUCTR2018-001405-87-ES
(EUCTR)
12/12/201818/01/2019A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Australia;Denmark;Peru;Germany
171EUCTR2017-004302-18-SE
(EUCTR)
03/12/201801/08/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
172NCT03727802
(ClinicalTrials.gov)
November 28, 201824/10/2018Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary FibrosisTRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: TRK-250;Drug: PlaceboToray Industries, IncNULLActive, not recruiting40 Years80 YearsAll34Phase 1United States
173NCT03711162
(ClinicalTrials.gov)
November 28, 201815/10/2018A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareA Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLTerminated40 YearsN/AAll526Phase 3United States;Australia;Belgium;Brazil;Chile;Czechia;Denmark;Germany;Greece;Japan;Peru;Spain;Taiwan;Turkey;United Kingdom
174EUCTR2017-004919-39-DE
(EUCTR)
20/11/201816/07/2018A study to test the safety, tolerability, biological activity, and pharmacokinetics of the drug ND-L02-s0201 compared with a placebo in patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ND-L02-s0201 for injection
INN or Proposed INN: TBC
Nitto Denko CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2Japan;United Kingdom;Germany;United States
175NCT03717012
(ClinicalTrials.gov)
November 15, 201819/10/2018Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoLIdiopathic Pulmonary FibrosisDrug: Nintedanib;Other: Pulmonary rehabilitation programBoehringer IngelheimNULLTerminated40 YearsN/AAll19Phase 4United States
176EUCTR2017-003158-18-DK
(EUCTR)
15/11/201816/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Korea, Republic of
177EUCTR2018-002632-24-FR
(EUCTR)
13/11/201820/07/2018to evaluate a triple therapy: plasma exchange, rituximab, intravenous immunoglobulin (IVIg) and corticosteroid administration compared to standard corticosteroid therapy in patients for severe acute exacerbation of idiopathic pulmonaryTherapeutic plasma exchange, rituximab and intravenous immunoglobulins (IVIg) for severe acute exacerbation of idiopathic pulmonary fibrosis admitted in ICU: an open, randomized, controlled trial - EXCHANGE-IFP severe acute exacerbation of idiopathic pulmonary fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: RIXATHON 500 mg
Trade Name: PRIVIGEN 100mg/ml
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
178NCT03733444
(ClinicalTrials.gov)
November 5, 20185/11/2018A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareA Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLTerminated40 YearsN/AAll781Phase 3United States;Argentina;Canada;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;South Africa
179EUCTR2017-004302-18-BG
(EUCTR)
22/10/201806/08/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
180NCT03711435
(ClinicalTrials.gov)
October 20, 20187/10/2018Traditional Chinese Medicine(TCM) Syndrome Classification of Idiopathic Pulmonary Fibrosis(IPF) and MetabolomicsStudy on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on MetabolomicsIdiopathic Pulmonary FibrosisDiagnostic Test: Metabolomics;Drug: Traditional Chinese Medicine FormulationXuzhou Traditional Chinese Medicine HospitalNULLCompleted50 Years85 YearsAll60China
181EUCTR2017-004302-18-FR
(EUCTR)
16/10/201803/08/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Egypt;France;Slovakia;Finland;Ukraine;Oman;Lebanon;Romania;Croatia;Bulgaria;Sweden
182EUCTR2017-003158-18-NL
(EUCTR)
10/10/201824/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - SPIRIT mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
183NCT03725852
(ClinicalTrials.gov)
September 27, 20188/6/2018A Clinical Study to Test How Effective and Safe GLPG1205 is for Patients With Idiopathic Pulmonary Fibrosis (IPF)A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GLPG1205;Drug: PlaceboGalapagos NVNULLCompleted40 YearsN/AAll69Phase 2Bulgaria;Croatia;Finland;France;Oman;Romania;Slovakia;Sweden;Ukraine
184EUCTR2017-003158-18-BE
(EUCTR)
26/09/201829/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Korea, Republic of
185NCT03573505
(ClinicalTrials.gov)
September 24, 201819/6/2018An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BG00011;Drug: PlaceboBiogenNULLTerminated40 YearsN/AAll109Phase 2United States;Argentina;Australia;Belgium;Chile;Czechia;Denmark;France;Greece;Israel;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom
186EUCTR2017-003158-18-GR
(EUCTR)
21/09/201825/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
187EUCTR2017-002667-17-IT
(EUCTR)
20/09/201813/02/2018Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis - Study of pharmacodynamics,pharmacokinetics, safety and tolerability of VAY736 in patients with idiop Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2United States;France;Canada;Ireland;Germany;United Kingdom;Italy
188EUCTR2017-003158-18-GB
(EUCTR)
18/09/201810/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - 203PF203 mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
189EUCTR2017-003158-18-CZ
(EUCTR)
12/09/201809/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
190NCT03286556
(ClinicalTrials.gov)
September 4, 201812/9/2017Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary FibrosisStudy of Therapeutic Plasma Exchange, Rituximab and Intravenous Immunoglobulin for Acute Exacerbations of Idiopathic Pulmonary Fibrosis (STRIVE-IPF)Idiopathic Pulmonary Fibrosis, Acute Fatal FormDrug: Autoantibody Reductive Therapy;Drug: Treatment as Usual (TAU)University of Alabama at BirminghamNational Heart, Lung, and Blood Institute (NHLBI);Brigham and Women's Hospital;Temple University;University of PittsburghRecruiting40 Years85 YearsAll51Phase 2United States
191EUCTR2017-003158-18-IT
(EUCTR)
03/09/201805/11/2020Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: NA
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: [BG00011]
INN or Proposed INN: Not yet assigned
BIOGEN IDEC RESEARCH LIMITEDNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Czechia;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of
192NCT03535545
(ClinicalTrials.gov)
August 1, 201811/5/2018Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis PatientsPreliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer Patients Undergoing Radiation Therapy Prior to the Resection of Locally Advanced Tumors, and Idiopathic Pulmonary Fibrosis PatientsPulmonary Fibrosis;Lung CancerDrug: [68Ga]CBP8;Diagnostic Test: PET ImagingMassachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 Years80 YearsAll25Phase 1United States
193EUCTR2017-003158-18-ES
(EUCTR)
27/07/201805/06/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
194NCT03619616
(ClinicalTrials.gov)
July 16, 201823/7/2018Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy AdultsA Phase 1 Randomized,Double-Blind,Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1603 in Chinese Healthy SubjectsIdiopathic Pulmonary Fibrosis(IPF);Solid TumorDrug: ZSP1603 7.5 mg;Drug: ZSP1603 12.5 mg;Drug: Placebo 12.5mg;Drug: ZSP1603 25 mg;Drug: Placebo 25mg;Drug: ZSP1603 50 mg;Drug: Placebo 50mgGuangdong Zhongsheng Pharmaceutical Co., Ltd.NULLCompleted18 Years50 YearsAll40Phase 1China
195EUCTR2017-004923-63-GB
(EUCTR)
10/07/201820/12/2017A study to test the safety, tolerability, and the effects of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF)A phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: C21
INN or Proposed INN: PD00377 Na-salt
Other descriptive name: COMPOUND 21
Vicore Pharma ABNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom;Bulgaria;Poland;Serbia
196NCT03928847
(ClinicalTrials.gov)
July 1, 201818/4/2019Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.Idiopathic Pulmonary FibrosisDrug: Epigallocatechin-3-gallate (EGCG)University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI)Recruiting40 Years70 YearsAll35Early Phase 1United States
197NCT03538301
(ClinicalTrials.gov)
June 18, 20182/5/2018JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPFA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: ND-L02-s0201;Other: Other: PlaceboNitto Denko CorporationNULLActive, not recruiting40 Years80 YearsAll120Phase 2United States;Germany;Japan;United Kingdom
198EUCTR2017-004302-18-SK
(EUCTR)
18/06/201804/05/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
199EUCTR2017-002667-17-FR
(EUCTR)
06/06/201820/02/2018Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
84 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Ireland;Germany;Italy;United Kingdom
200EUCTR2017-002667-17-DE
(EUCTR)
04/06/201823/01/2018Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
58Phase 2United States;France;Canada;Ireland;Germany;United Kingdom;Italy
201NCT03688334
(ClinicalTrials.gov)
June 1, 201820/9/2018Acute Effects of Oxygen Supplementation Among IPF PatientsAcute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting HypoxemiaIdiopathic Pulmonary FibrosisDrug: Oxygen 40 %;Drug: Medical air (sham O2)George Papanicolaou HospitalNULLUnknown status18 Years80 YearsAll15N/AGreece
202EUCTR2016-003827-45-GR
(EUCTR)
29/05/201816/05/2018AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONEAN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE - MADIET Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
CIBERES - Instituto Carlos IIIInstitut d'Investigació Biomédica de Bellvitge (IDIBELL)Not RecruitingFemale: yes
Male: yes
90Phase 4Greece;Spain;United Kingdom
203EUCTR2017-002667-17-GB
(EUCTR)
18/05/201808/11/2017Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2United States;France;Canada;United Kingdom;Italy;Germany;Ireland
204EUCTR2016-003827-45-GB
(EUCTR)
15/05/201801/02/2018AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONEAN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE - MADIET (version 1.6) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
CIBER - Instituto Carlos IIIInstitut d'Investigació Biomédica de Bellvitge (IDIBELL)Authorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGreece;Spain;United Kingdom
205NCT03502902
(ClinicalTrials.gov)
April 26, 201810/4/2018The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female SubjectsA Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female SubjectsIdiopathic Pulmonary FibrosisDrug: HEC 68498;Drug: PlaceboSunshine Lake Pharma Co., Ltd.CovanceCompleted18 Years60 YearsAll55Phase 1United States
206NCT03500731
(ClinicalTrials.gov)
April 19, 201830/3/2018Lung and Bone Marrow Transplantation for Lung and Bone Marrow FailureLung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow FailureIdiopathic Pulmonary Fibrosis;Emphysema or COPDBiological: CD3/CD19 negative hematopoietic stem cells;Drug: Rituximab;Drug: Alemtuzumab;Drug: Fludarabine;Drug: Thiotepa;Drug: G-CSF;Drug: HydroxyureaPaul SzabolcsNULLRecruiting18 Years60 YearsAll8Phase 1/Phase 2United States
207EUCTR2017-002667-17-IE
(EUCTR)
06/04/201808/11/2017Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
58Phase 2United States;France;Canada;Ireland;Germany;United Kingdom;Italy
208NCT03422068
(ClinicalTrials.gov)
March 16, 201822/1/2018This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy.Idiopathic Pulmonary FibrosisDrug: BI 1015550;Drug: PlaceboBoehringer IngelheimNULLCompleted40 YearsN/AAll15Phase 1Belgium;Denmark;Finland;Germany;Italy;Netherlands;Spain;United Kingdom;France
209NCT02871401
(ClinicalTrials.gov)
January 3, 201815/8/2016A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)A Phase One-B (1B) Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Valganciclovir;Drug: PlaceboVanderbilt University Medical CenterGenentech, Inc.Completed21 Years80 YearsAll31Phase 1United States
210NCT03287414
(ClinicalTrials.gov)
December 20, 201712/9/2017Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary FibrosisA Subject-, Investigator-, and Sponsor-blinded, Randomized, Placebo-controlled, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of VAY736 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: VAY736;Drug: Placebo;Drug: Standard of Care (SoC)Novartis PharmaceuticalsNULLTerminated40 Years80 YearsAll30Phase 2United States;Canada;Germany;Ireland;Italy;United Kingdom;France
211NCT03183570
(ClinicalTrials.gov)
November 8, 20178/5/2017Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CTDetection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CTIdiopathic Pulmonary Fibrosis;Primary Sclerosing Cholangitis;Covid19 PneumoniaDrug: [18F]FP-R01-MG-F2Stanford UniversityPliant Therapeutics, Inc.Recruiting18 YearsN/AAll30Early Phase 1United States
212NCT03281200
(ClinicalTrials.gov)
October 24, 201711/9/2017Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in SpainA Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain.Idiopathic Pulmonary FibrosisDrug: L - Antineoplastic and immunomodulating agents;Drug: L01 - Antineoplastic agents;Drug: L01X - Other antineoplastic agents;Drug: L01XE - Protein kinase inhibitors;Drug: L01XE31 - NintedanibBoehringer IngelheimNULLCompleted18 YearsN/AAll172Spain
213NCT03208933
(ClinicalTrials.gov)
October 23, 201726/6/2017Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical PracticeIdiopathic Pulmonary FibrosisDrug: PirfenidoneHoffmann-La RocheNULLCompleted40 Years80 YearsAll60Phase 3Russian Federation
214JPRN-UMIN000029411
2017/10/1515/10/2017Phase III study of perioperative pirfenidone therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) for confirming the effect for prevention of postoperative acute exacerbation non-small-cell lung cancer combined with idiopathic pulmonary fibrosisOral pirfenidone (600mg) is administrated for 14days after registration, and oral pirfenidone (1200mg) for more 14days before surgery. It's recommended continuing oral pirfenidone as long as possible even after surgery.
Acute exacerbation prophylaxis is performed (not specified. but decided in each facility)
North East Japan Study GroupNULLRecruiting20years-oldNot applicableMale and Female230Phase 3Japan
215EUCTR2016-003473-17-GB
(EUCTR)
14/09/201724/02/2017Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary Fibrosis A Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis IDIOPATHIC PULMONARY FIBROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: CC-90001
INN or Proposed INN: Not available
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Turkey;Russian Federation;Colombia;United Kingdom;France;Canada;Brazil;Romania;Australia;Germany
216JPRN-UMIN000026376
2017/09/0103/03/2017Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary FibrosisLong-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis - Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in IPF Idiopathic pulmonary fibrosis(IPF)Short-term induction pulmonary rehabilitation (2/1w for the first 12w) + Maintenance pulmonary rehabilitation and outpatient visit (1/4w) Total 52w. / No intervention
Nintedanib / both group
Central Japan Lung Study GrouNULLComplete: follow-up complete40years-old80years-oldMale and Female84Phase 4Japan
217EUCTR2017-001276-27-GB
(EUCTR)
21/08/201703/05/2017A study to determine if GBT440 can increase the level of oxygen in the blood of people with Idiopathic Pulmonary Fibrosis (IPF) who need to use supplemental oxygen when resting.A Phase II open label study to evaluate the effect of GBT440 on hypoxemia in subjects with Idiopathic Pulmonary Fibrosis (IPF) who are using supplemental oxygen at rest (ZEPHYR) - ZEPHYR Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GBT440 300 mg capsule
Product Code: GBT440
Product Name: GBT440 300 mg tablet
Product Code: GBT440
Global Blood Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
32 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;United Kingdom
218NCT03142191
(ClinicalTrials.gov)
July 26, 201724/4/2017A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary FibrosisA Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Fibrosis;Idiopathic Interstitial Pneumonias;Pathologic Processes;Lung Diseases, Interstitial;Lung Diseases;Respiratory Tract DiseasesDrug: CC-90001;Other: PlaceboCelgeneNULLCompleted40 YearsN/AAll138Phase 2United States;Australia;Brazil;Canada;Colombia;Germany;Greece;Romania;Russian Federation;Taiwan;Turkey;Ukraine;United Kingdom;China
219EUCTR2015-002619-14-FR
(EUCTR)
21/06/201725/04/2018Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairmentA 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
220NCT03069989
(ClinicalTrials.gov)
June 13, 201728/2/2017Single Doses of GSK3008348 in Idiopathic Pulmonary Fibrosis (IPF) Participants Using Positron Emission Tomography (PET) ImagingA Study of Single Doses to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of Nebulised GSK3008348 in Idiopathic Pulmonary Fibrosis Patients, Using Positron Emission Tomography (PET) ImagingIdiopathic Pulmonary FibrosisDrug: GSK3008348;Drug: Placebo;Drug: [18F]-FBA-A20FMDV2GlaxoSmithKlineNULLTerminated50 YearsN/AAll8Phase 1United Kingdom
221JPRN-jRCTs071180049
23/05/201715/03/2019Japanese Intergroup Study of Nintedanib for NSCLC with IPFA randomized phase III study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - J-SONIC Advanced Non-small cell lung cancer with idiopathic pulmonary fibrosiscarboplatin + nab-paclitaxel
carboplatin + nab-paclitaxel + nintedanib
Okamoto IsamuOtsubo KoheiNot Recruiting>= 20age oldNot applicableBoth240Phase 3Japan
222NCT03092102
(ClinicalTrials.gov)
May 20, 201721/3/2017The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female SubjectsA Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female SubjectsIdiopathic Pulmonary FibrosisDrug: HEC585Sunshine Lake Pharma Co., Ltd.NULLCompleted18 Years60 YearsAll136Phase 1United States
223JPRN-UMIN000026799
2017/05/1201/04/2017A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosisA randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - Japanese Intergroup Study of Nintedanib for NSCLC with IPF (J-SONIC) Non-small-cell lung cancer with idiopathic pulmonary fibrosisA: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) repeated every 3 weeks
B: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) in combination with nintedanib (150 mg B.I.D, daily) repeated every 3 weeks followed by single-agent administration of nintedanib (150 mg B.I.D, daily)
Research Institute for Diseases of the Chest, Kyushu UniversityNULLComplete: follow-up continuing20years-oldNot applicableMale and Female240Phase 3Japan
224EUCTR2016-003473-17-GR
(EUCTR)
05/05/201702/03/2017Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary FibrosisA Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis IDIOPATHIC PULMONARY FIBROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: CC-90001Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 2United States;Taiwan;Greece;Turkey;Russian Federation;Colombia;United Kingdom;France;Canada;Brazil;Romania;Australia;Germany
225NCT03115619
(ClinicalTrials.gov)
April 18, 201712/4/2017Quality of Life Study in Participants With IPF Under Pirfenidone TreatmentA Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Quality of Life in Patients in Greece With Idiopathic Pulmonary Fibrosis Under Treatment With Pirfenidone - The Pneumon StudyIdiopathic Pulmonary FibrosisDrug: PirfenidoneHoffmann-La RocheNULLCompleted18 YearsN/AAll102Greece
226NCT02759120
(ClinicalTrials.gov)
March 22, 201728/4/2016CleanUP IPF for the Pulmonary Trials CooperativeStudy of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Antimicrobial therapy: Co-trimoxazole or Doxycycline;Other: No Intervention: Standard of CareWeill Medical College of Cornell UniversityDuke Clinical Research Institute;University of Chicago;University of Washington;University of Pittsburgh;National Heart, Lung, and Blood Institute (NHLBI)Terminated40 YearsN/AAll509Phase 3United States
227EUCTR2015-005131-40-CZ
(EUCTR)
20/03/201716/12/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
228EUCTR2015-005131-40-HU
(EUCTR)
16/01/201701/12/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany
229NCT02951429
(ClinicalTrials.gov)
December 31, 201628/10/2016Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary HypertensionA Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Group 3 Pulmonary HypertensionIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: Placebo;Drug: SildenafilHoffmann-La RocheNULLCompleted40 Years80 YearsAll177Phase 2Belgium;Canada;Czechia;Egypt;Germany;Greece;Hungary;Israel;Italy;Netherlands;South Africa;Spain;Turkey;Czech Republic;United Arab Emirates
230NCT02874989
(ClinicalTrials.gov)
December 16, 201617/8/2016Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human TrialTargeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: Dasatinib + Quercetin;Drug: PlaceboWake Forest University Health SciencesMayo Clinic;The University of Texas Health Science Center at San AntonioCompleted50 YearsN/AAll26Phase 1United States
231EUCTR2015-005131-40-BE
(EUCTR)
16/12/201620/10/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
232EUCTR2015-005131-40-DE
(EUCTR)
08/12/201625/10/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Addedto Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis andRisk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTSWITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
233EUCTR2015-005131-40-GR
(EUCTR)
06/12/201603/11/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
234EUCTR2015-005131-40-NL
(EUCTR)
02/12/201613/10/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany
235EUCTR2015-005131-40-IT
(EUCTR)
09/11/201625/05/2021A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. - na Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: ESBRIET
Product Code: [RO0220912]
INN or Proposed INN: 00322900
Trade Name: Sildenafil
Product Name: sildenafil
Product Code: [G048E03]
INN or Proposed INN: 00258901
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Czechia;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
236EUCTR2015-003148-38-PL
(EUCTR)
08/11/201604/10/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
237NCT03050255
(ClinicalTrials.gov)
November 201625/11/2016Short-term Effects of Supplemental Oxygen in Patients With IPFShort-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Other: Medical air;Other: Oxygen (2Liter/min);Other: Oxygen (4Liter/min)Schön Klinik Berchtesgadener LandLinde AGCompletedN/AN/AAll53N/AGermany
238NCT02989168
(ClinicalTrials.gov)
November 201628/11/2016Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at RestA Phase II Open Label Study to Evaluate the Effect of GBT440 on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Who Are Using Supplemental Oxygen at Rest (ZEPHYR)Idiopathic Pulmonary Fibrosis;HypoxemiaDrug: GBT440Global Blood TherapeuticsNULLTerminated45 Years85 YearsAll14Phase 2United States;United Kingdom
239EUCTR2015-005131-40-ES
(EUCTR)
20/10/201609/09/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
240EUCTR2015-002619-14-IT
(EUCTR)
01/09/201604/06/2021Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(TM):A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: Nintedanib
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: Nintedanib
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
241EUCTR2014-004782-24-HU
(EUCTR)
09/08/201614/04/2016A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Code: PRM-151
INN or Proposed INN: PRM-151
Promedior, Inc.NULLNot RecruitingFemale: yes
Male: yes
117Phase 2United States;Czech Republic;Hungary;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy
242EUCTR2015-002619-14-GB
(EUCTR)
01/08/201608/09/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
243NCT02885961
(ClinicalTrials.gov)
August 201615/8/2016The Coagulation Cascade in Idiopathic Pulmonary FibrosisInvestigating the Role of the Coagulation Cascade in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;IPF;Interstitial Lung DiseaseDrug: Dabigatran;Radiation: FDG PET scanUniversity College, LondonNULLNot yet recruiting40 Years80 YearsBoth12N/ANULL
244EUCTR2015-002619-14-BE
(EUCTR)
25/07/201603/06/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE (TM) : A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE (TM) patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
SCS Boehringer Ingelheim Comm. VNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
245EUCTR2015-002619-14-DE
(EUCTR)
21/07/201604/05/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
246EUCTR2015-003148-38-DE
(EUCTR)
14/07/201620/05/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
247NCT02802345
(ClinicalTrials.gov)
June 30, 201614/6/2016Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function ImpairmentINSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function ImpairmentIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: Placebo;Drug: SildenafilBoehringer IngelheimNULLCompleted40 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom
248EUCTR2015-002619-14-ES
(EUCTR)
29/06/201617/05/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentA 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
249EUCTR2015-003148-38-ES
(EUCTR)
13/06/201611/03/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
250NCT02788474
(ClinicalTrials.gov)
June 9, 201627/5/2016Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity ImpairmentA 12-week, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Followed by a Single Active Arm Phase of 40 Weeks Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on Change in Biomarkers of Extracellular Matrix (ECM) Turnover in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Limited Forced Vital Capacity (FVC) Impairment.Idiopathic Pulmonary FibrosisDrug: nintedanib;Drug: placeboBoehringer IngelheimNULLCompleted40 YearsN/AAll347Phase 4United States;Australia;Belgium;Czechia;Finland;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Spain;United Kingdom;Czech Republic
251EUCTR2015-003148-38-GB
(EUCTR)
06/06/201618/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
252EUCTR2015-003148-38-BE
(EUCTR)
06/06/201619/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
SCS Boehringer Ingelheim Comm. VNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
253NCT02846324
(ClinicalTrials.gov)
June 20167/7/2016Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPFA Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis;HypoxemiaDrug: GBT440;Drug: PlaceboGlobal Blood TherapeuticsNULLCompleted45 Years80 YearsAll39Phase 2United States
254EUCTR2015-003148-38-HU
(EUCTR)
27/05/201612/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
255EUCTR2015-003148-38-CZ
(EUCTR)
26/05/201611/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of;United States
256EUCTR2015-003148-38-FR
(EUCTR)
24/05/201604/05/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
257EUCTR2015-003148-38-FI
(EUCTR)
17/05/201612/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
258EUCTR2015-004157-41-IT
(EUCTR)
13/05/201601/10/2021Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Stu Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
Other descriptive name: GLPG1690
GALAPAGOS NVNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom;Italy
259JPRN-JapicCTI-163326
01/5/201622/07/2016Phase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosisPhase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosis Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF)Intervention name : ART-123
INN of the intervention : thrombomodulin alfa
Dosage And administration of the intervention : 380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo by intravenous drip infusion in addition to standard of care steroid therapy
ASAHI KASEI PHARMA CORPORATIONNULLrecruiting4085BOTHPhase 3NULL
260NCT02688647
(ClinicalTrials.gov)
May 201618/2/2016A Phase 2 Study of the Activity and Safety of KD025 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: KD025;Other: BSCKadmon Corporation, LLCNULLCompleted18 YearsN/AAll76Phase 2United States
261NCT02739165
(ClinicalTrials.gov)
May 20161/4/2016Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary FibrosisPhase III Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Multicenter Randomized Placebo-controlled Double-blind Study to Assess the Efficacy and Safety of ART-123Idiopathic Pulmonary FibrosisDrug: ART-123;Drug: PlaceboAsahi Kasei Pharma CorporationNULLCompleted40 Years85 YearsAll74Phase 3Japan
262EUCTR2015-003280-11-NL
(EUCTR)
29/04/201619/01/2016A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Germany;Netherlands;Italy
263EUCTR2014-004782-24-CZ
(EUCTR)
25/04/201611/08/2015A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Code: PRM-151
INN or Proposed INN: PRM-151
Promedior, Inc.NULLNot Recruiting Female: yes
Male: yes
117 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Czech Republic;Spain;Belgium;Netherlands;Germany;United Kingdom
264JPRN-UMIN000022037
2016/04/1924/04/2016The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs. Advanced NSCLC patients with IIPsNivolumab 3mg/kg, every 2 weeksKobe city medical center general hospitalNULLComplete: follow-up complete20years-old100years-oldMale and Female6Not selectedJapan
265NCT02606877
(ClinicalTrials.gov)
April 19, 201616/11/2015A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in CombinationInvestigation of Drug-drug Interaction Between Nintedanib and Pirfenidone in Patients With IPF (an Open Label, Multiple-dose, Two Group Study)Idiopathic Pulmonary FibrosisDrug: nintedanib;Drug: pirfenidoneBoehringer IngelheimNULLCompleted40 YearsN/AAll37Phase 4United Kingdom
266JPRN-UMIN000021591
2016/04/0401/04/2016The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumoniaThe pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia - The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia Advanced non-small cell lung cancer with idiopathic interstitial pneumoniacarboplatin AUC6 D1
paclitaxel 200mg/m D1
tryweekly 4cycle
nintedanib 150mg twice daily
Hirosaki University Graduate School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
267NCT02745184
(ClinicalTrials.gov)
April 201615/4/2016Clinical Efficacy and Safety of Autologous Lung Stem Cell Transplantation in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: Lung stem cellsShanghai East HospitalRegend TherapeuticsRecruiting40 Years75 YearsAll20Phase 1/Phase 2China
268EUCTR2014-004782-24-ES
(EUCTR)
31/03/201615/12/2015A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Code: PRM-151
INN or Proposed INN: PRM-151
Promedior, Inc.NULLNot Recruiting Female: yes
Male: yes
117 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom;Germany;Netherlands;Spain;Belgium;Czech Republic;Hungary;United States
269EUCTR2015-004157-41-GB
(EUCTR)
21/03/201602/12/2015Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
Other descriptive name: GLPG1690
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUkraine;United Kingdom
270EUCTR2014-004782-24-DE
(EUCTR)
01/03/201619/05/2015A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Code: PRM-151
INN or Proposed INN: PRM-151
Promedior, Inc.NULLNot RecruitingFemale: yes
Male: yes
117Phase 2United States;Hungary;Czech Republic;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy
271NCT02738801
(ClinicalTrials.gov)
March 201611/4/2016Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: GLPG1690 600 mg QD;Drug: Placebo QDGalapagos NVNULLCompleted40 YearsN/AAll23Phase 2Ukraine;United Kingdom;Italy
272NCT02503657
(ClinicalTrials.gov)
March 201614/7/2015Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Placebo-Controlled, Double-Blind Six Month Study Followed by an Open-Label Extension Phase to Evaluate the Efficacy, Safety and Tolerability of MN-001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis;IPFDrug: tipelukast;Drug: PlaceboMediciNovaNULLActive, not recruiting21 Years80 YearsAll15Phase 2United States
273EUCTR2015-003280-11-DE
(EUCTR)
25/02/201619/10/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
274EUCTR2014-005658-20-BG
(EUCTR)
23/02/201618/12/2015FG-3019 treatment in Idiopathic Pulmonary Fibrosis (IPF) patients.A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;Level: HLT;Classification code 10033979;Term: Parenchymal lung disorders NEC;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: FG-3019 10mg/mL in 10 mL vials
Product Code: FG-3019
INN or Proposed INN: Pamrevlumab
FibroGen, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 2United States;Canada;Australia;South Africa;Bulgaria;New Zealand;India
275EUCTR2014-003933-24-PT
(EUCTR)
15/02/201607/10/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597
INN or Proposed INN: NA
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
276JPRN-UMIN000020722
2016/01/2625/01/2016Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis idiopathic pulmonary fibrosisadministration of 150mg of nintedanib twice dailyKanagawa Cardiovascular and Respiratory CenterNULLRecruiting40years-oldNot applicableMale and Female30Not applicableJapan
277JPRN-UMIN000020682
2016/01/2222/01/2016The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosisThe comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis - The comparison of antifibrotic agents in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosispirfenidone 12 months 200-600mg t.i.d or b.i.d
nintedanib 12 months 100-150mg b.i.d
National Hospital Organization Ibarakihigashi National HospitalThe center of Chest Diseases and Severe Motor&Intellectual DisabilitiesNULLPending20years-oldNot applicableMale and Female60Not applicableJapan
278EUCTR2015-003280-11-DK
(EUCTR)
20/01/201625/11/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
279NCT02648048
(ClinicalTrials.gov)
January 15, 20165/1/2016A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary FibrosisA Single Arm, Multicenter, Open-label, Phase 1b Study to Assess the Safety and Tolerability of Oral Vismodegib in Combination With Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: VismodegibHoffmann-La RocheNULLCompleted40 Years80 YearsAll21Phase 1United States;Germany
280NCT02598193
(ClinicalTrials.gov)
January 14, 20164/11/2015Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneHoffmann-La RocheNULLCompleted40 Years80 YearsAll89Phase 4United States;Canada;Denmark;France;Germany;Italy;Netherlands;Spain
281EUCTR2014-004782-24-IT
(EUCTR)
22/12/201506/09/2021A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - PRM-151-202 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Code: PRM-151PROMEDIOR, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
117Phase 2France;United States;Czechia;Hungary;Czech Republic;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy
282EUCTR2015-000640-42-IT
(EUCTR)
22/12/201522/02/2018Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib incombination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - - Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
INN or Proposed INN: nintedanib
Other descriptive name: nintedanib
Trade Name: Ofev
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
283EUCTR2015-003280-11-IT
(EUCTR)
17/12/201527/05/2021A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET¿) IN COMBINATION WITH NINTEDANIB (OFEV¿) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS - NA Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ESBRIET - 267 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) 270 CAPSULE
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
INN or Proposed INN: NINTEDANIB
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
284EUCTR2015-003280-11-ES
(EUCTR)
16/12/201530/10/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Roche Farma S.A., que representa en España a F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
285NCT02612051
(ClinicalTrials.gov)
December 4, 201519/11/2015First Time in Human (FTIH) Study of GSK3008348 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis PatientsA FTIH Study With GSK3008348 in Healthy Volunteers and Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GSK3008348 Nebuliser solution;Drug: Placebo Nebuliser solution;Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusionGlaxoSmithKlineNULLCompleted18 YearsN/AAll40Phase 1United Kingdom
286EUCTR2014-000861-32-DE
(EUCTR)
01/12/201502/09/2015Standard-armed controlled study to assess the impact of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF)Exploring Efficacy and Safety of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF)A randomized, double-blind, placebo-controlled, parallel group, multi-center, phase II trial - RELIEF 1.Fibrotic NSIP., 2.Chronic Hypersensitivity Pneumonitis 3. Lung fibrosis associated with collagen / vascular diseases, 4.Asbestos-induced lung fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10022612;Term: Interstitial lung fibrosis;System Organ Class: 100000004855
MedDRA version: 20.0;Classification code 10035754;Term: Pneumonitis hypersensitivity;Classification code 10025088;Term: Lung fibrosis;Classification code 10022617;Term: Interstitial pneumonia;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet® (Pirfenidon)
Product Name: Esbriet® (Pirfenidon)
Product Code: PZN 8881655(RochePharma AG)
INN or Proposed INN: PIRFENIDONE
Justus Liebig Universität GiessenNULLNot RecruitingFemale: yes
Male: yes
374Phase 2Germany
287EUCTR2015-000640-42-DE
(EUCTR)
01/12/201503/09/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF Idiopathic Pulmonary Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim Pharma GmbH & Co.KGNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
288NCT02551068
(ClinicalTrials.gov)
December 20151/9/2015High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With NintedanibHigh Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF StudyIdiopathic Pulmonary FibrosisOther: 60% Oxygen;Other: Standard of CareUniversity of British ColumbiaBoehringer IngelheimRecruiting19 YearsN/AAll88N/ACanada
289NCT02460588
(ClinicalTrials.gov)
December 201516/3/2015Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary FibrosisCyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized TrialIdiopathic Pulmonary FibrosisDrug: Cyclophosphamide;Drug: Placebo;Drug: Corticosteroid (prednisolone)Assistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll120Phase 3France
290EUCTR2015-000492-27-FR
(EUCTR)
24/11/201511/09/2015N/AN/A - EXAFIP
MedDRA version: 18.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855
Trade Name: ENDOXAN
Product Name: ENDOXAN
INN or Proposed INN: Cyclosphamine
Other descriptive name: ENDOXAN
Trade Name: UROMITEXAN
Product Name: UROMITEXAN
INN or Proposed INN: MESNA
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
120Phase 3France
291EUCTR2014-004782-24-BE
(EUCTR)
06/11/201527/05/2015A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Code: PRM-151
INN or Proposed INN: PRM-151
Promedior, Inc.NULLNot Recruiting Female: yes
Male: yes
117 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
292JPRN-UMIN000019436
2015/10/1621/10/2015Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone idiopathic pulmonary fibrosisNintedanib+pirfenidone group;
Nintedanib 150mg twice daily
Pirfenidone 600-1800mg/day
Nintedanib group;
Nintedanib 150mg twice daily
Kanagawa Cardiovascular and Respiratory CenterNULLComplete: follow-up complete40years-oldNot applicableMale and Female60Phase 2Japan
293NCT02579603
(ClinicalTrials.gov)
October 16, 201516/10/2015Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPFA Twelve Week, Open-label, Randomised, Parallel-group Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Oral Nintedanib in Combination With Oral Pirfenidone, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneBoehringer IngelheimNULLCompleted40 YearsN/AAll105Phase 4United States;Canada;France;Germany;Italy;Netherlands
294EUCTR2015-000640-42-NL
(EUCTR)
13/10/201518/08/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF Idiopathic Pulmonary Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Germany;Netherlands;Italy
295NCT02550873
(ClinicalTrials.gov)
September 7, 201527/8/2015A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisBiological: PRM-151;Other: placeboHoffmann-La RocheNULLCompleted40 Years80 YearsAll117Phase 2United States;Czechia;Germany;Italy;Netherlands;Spain;Switzerland;Belgium;Czech Republic;Israel;United Kingdom
296NCT02607722
(ClinicalTrials.gov)
August 31, 20152/9/2015All-Case Surveillance of Ofev in Patients With IPF in JapanThe Special Drug Use-results Survey (All-Case Surveillance) of Ofev® Capsules in Patients With Idiopathic Pulmonary Fibrosis (IPF) in JapanIdiopathic Pulmonary FibrosisDrug: NintedanibBoehringer IngelheimNULLRecruitingN/AN/AAll6000Japan
297EUCTR2014-003933-24-DE
(EUCTR)
31/08/201502/03/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
298NCT02502097
(ClinicalTrials.gov)
August 26, 201516/7/2015A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016)A Randomized Placebo-Controlled Study to Assess the Efficacy and Safety of AF-219, a P2X3 Receptor Antagonist, in Subjects With Idiopathic Pulmonary Fibrosis (IPF) With Persistent CoughIdiopathic Pulmonary Fibrosis;CoughDrug: Gefapixant;Other: PlaceboAfferent Pharmaceuticals, Inc.NULLCompleted40 YearsN/AAll51Phase 2United States
299EUCTR2015-000640-42-FR
(EUCTR)
26/08/201505/08/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
135Phase 4United States;France;Canada;Netherlands;Germany;Italy
300EUCTR2014-003933-24-GB
(EUCTR)
29/07/201505/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
301NCT02477709
(ClinicalTrials.gov)
July 20, 201517/6/2015A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)A Study to Assess the Tolerability of a Single Dose of AF-219, a P2X3 Receptor Antagonist, in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: GefapixantAfferent Pharmaceuticals, Inc.NULLCompleted40 YearsN/AAll6Phase 2United States
302NCT02538536
(ClinicalTrials.gov)
July 201525/8/2015A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)Drug: PBI4050Liminal BioSciences Ltd.NULLCompleted40 YearsN/AAll41Phase 2Canada
303NCT01841307
(ClinicalTrials.gov)
July 201523/4/2013Cromolyn Detection of Silent AspirationDevelopment and Validation of Test for Gastro-esophageal Reflux and AspirationGastroesophageal Reflux;Respiratory Aspiration;Idiopathic Pulmonary Fibrosis;Lung TransplantationDrug: Cromolyn SodiumUniversity of California, San FranciscoAradign Corportation;National Heart, Lung, and Blood Institute (NHLBI)Terminated18 Years70 YearsAll16Phase 1United States
304EUCTR2014-003933-24-GR
(EUCTR)
14/05/201522/06/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of
305EUCTR2014-003933-24-FR
(EUCTR)
12/05/201503/06/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of
306EUCTR2014-003933-24-IT
(EUCTR)
06/05/201527/05/2021Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - DRI11772 Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SAR156597SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy
307EUCTR2014-004782-24-NL
(EUCTR)
06/05/201508/12/2014A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.A Pilot Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Code: PRM-151Promedior incNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Netherlands
308NCT02345070
(ClinicalTrials.gov)
May 1, 201519/1/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging StudyIdiopathic Pulmonary FibrosisDrug: SAR156597;Drug: placeboSanofiNULLCompleted40 YearsN/AAll327Phase 2United States;Argentina;Australia;Canada;Chile;Colombia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Mexico;Portugal;Spain;Turkey;United Kingdom;Czech Republic
309NCT02267655
(ClinicalTrials.gov)
May 20157/10/20143 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPFAn Exploratory, 3-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects With World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated With Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects With WHO Group 3 PH Associated With Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)Pulmonary Hypertension;Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary FibrosisDrug: inhaled Nitric Oxide - 30 mcg/kg IBW/hr;Drug: inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr;Drug: inhaled nitric oxide 75 mcg/kg IBW/hrBellerophonNULLCompleted40 Years80 YearsAll8Phase 1Belgium
310NCT02478268
(ClinicalTrials.gov)
May 201516/6/2015Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary FibrosisUsing MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Hyperpolarized 129-Xenon gas;Device: MRIBastiaan DriehuysUniversity of Wisconsin, Madison;National Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll64Phase 1United States
311EUCTR2014-003933-24-ES
(EUCTR)
30/04/201503/03/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597
INN or Proposed INN: NA
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of;Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy
312EUCTR2014-003933-24-CZ
(EUCTR)
10/04/201513/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
313EUCTR2014-003933-24-DK
(EUCTR)
07/04/201520/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SAR156597
Product Code: SAR156597
INN or Proposed INN: SAR156597
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Australia;Germany;Korea, Republic of
314JPRN-UMIN000016826
2015/03/3131/03/2015The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis.The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis. - The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis (IPF)Pirfenidone
Observation
National Hospital Organization Ibarakihigashi National HospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female40Not applicableJapan
315NCT02397005
(ClinicalTrials.gov)
March 201527/2/2015Study of the Tolerability and Pharmacokinetic of ZL-2102 With an Investigation of Food Effect in Healthy Male SubjectsRandomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of ZL-2102 With a Pilot Investigation of Food Effect in Healthy Male SubjectsChronic Obstructive Pulmonary Disease;Asthma;Idiopathic Pulmonary FibrosisDrug: ZL-2102;Drug: Placebo matching ZL-2102Zai Lab Pty. Ltd.NULLActive, not recruiting18 Years45 YearsMale120Phase 1Australia
316EUCTR2014-004025-40-NL
(EUCTR)
06/02/201511/12/2014Treatment of chronic cough with PA101.Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101. - Treatment of chronic cough with PA101 Chronic Idiopathic Cough and Chronic Cough in Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Disodium Cromoglycate [cromolyn sodium]
Product Code: PA101
INN or Proposed INN: Not available
Other descriptive name: Disodium cromoglycate (DSCG)
Patara PharmaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Netherlands;United Kingdom
317NCT02412020
(ClinicalTrials.gov)
February 20153/4/2015Treatment of Refractory Chronic Cough With PA101Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101Refractory Chronic CoughDrug: PA101;Drug: PlaceboPatara PharmaNULLCompleted18 Years75 YearsBoth52Phase 2Netherlands;United Kingdom
318JPRN-UMIN000015508
2015/01/0124/10/2014A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosisUsing Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks.
Pirfenidone 1200-1800mg (control group)
Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan.NULLComplete: follow-up complete40years-oldNot applicableMale and Female150Not selectedJapan
319ChiCTR-OOC-15005841
2015-01-012015-01-17Montelukast Sodium Tablets treatment clinical study for intractable cough by idiopathic pulmonary fibrosisMontelukast Sodium Tablets treatment clinical study for intractable cough by idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosisMontelukast Sodium Tablets treatment group :Montelukast Sodium Tablets: oral, 1 tablets each time (10mg), 1 time a day, at bedtime, for a period of 12 weeks;control group :Don't take Montelukast Sodium Tablets;Shanghai Pulmonary HospitalNULLRecruiting5080BothMontelukast Sodium Tablets treatment group :30;control group :30;NULL
320ChiCTR-OOC-15005840
2015-01-012015-01-17The significance in prevention of acute exacerbations of IPF by oral administration of eight anabacteriaAn observational study of the significance in prevention of acute exacerbations of IPF by oral administration of eight anabacteria Idiopathic pulmonary fibrosisThe immune-based treatment group :oral Broncho-Vaxom ;no immunotherapeutic group :no immunomodulator treatment ;Shanghai Pulmonary HospitalNULLRecruiting5080BothThe immune-based treatment group :60;no immunotherapeutic group :60;China
321ChiCTR-OOC-15005862
2015-01-012015-01-19The clinical study of the treatment by Granulocyte colony stimulating factor for idiopathic pulmonary fibrosis.An Open-label, parallel, randomized controlled clinical study of the treatment by Granulocyte colony stimulating factor for idiopathic pulmonary fibrosis. idiopathic pulmonary fibrosistreatment group:subcutaneous injection of Granulocyte colony stimulating factor termly;control group:no processing;Shanghai Pulmonary HospitalNULLRecruiting5080Bothtreatment group:50;control group:50;China
322NCT02485886
(ClinicalTrials.gov)
January 201526/6/201568Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary FibrosisSafety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: 68Ga-BMV101Peking Union Medical College HospitalStanford UniversityUnknown status18 YearsN/AAll20Early Phase 1China
323EUCTR2014-004058-32-GB
(EUCTR)
19/12/201412/06/2015Treating pulmonary fibrosis with co-trimoxazoleThe Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary Fibrosis with the Addition of Co-trimoxazole (EME-TIPAC) - Treating pulmonary fibrosis with co-trimoxazole Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cotrimoxazole
Product Name: Cotrimoxazole
Product Code: NA
INN or Proposed INN: trimethoprim
Other descriptive name: none
INN or Proposed INN: sulphamethoxazole
Other descriptive name: none
Norfolk and Norwich University Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
330Phase 3United Kingdom
324EUCTR2014-004025-40-GB
(EUCTR)
09/12/201406/01/2015Treatment of chronic cough with PA101.Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101. - Treatment of chronic cough with PA101 Chronic Idiopathic Cough and Chronic Cough in Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Disodium Cromoglycate [cromolyn sodium]
Product Code: PA101
Other descriptive name: Disodium cromoglycate (DSCG)
Patara PharmaNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands;United Kingdom
325NCT02230982
(ClinicalTrials.gov)
November 12, 201429/8/2014Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary FibrosisMulti-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: nintedanibBoehringer IngelheimNULLNo longer available40 YearsN/AAllBrazil
326JPRN-JapicCTI-142708
24/10/201414/11/2014A phase II study of LebrikizumabA PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY IDIOPATHIC PULMONARY FIBROSISIntervention name : RO5490255
INN of the intervention : Lebrikizumab
Dosage And administration of the intervention : 250mg SC injection every 4 weeks
Control intervention name : Placebo
Dosage And administration of the control intervention : SC injection every 4 weeks
Chugai Pharmaceutical Co., Ltd.NULL40BOTH480Phase 2NULL
327NCT04016168
(ClinicalTrials.gov)
October 22, 20148/7/2019Idiopathic Pulmonary Fibrosis and Serum BankIdiopathic Pulmonary Fibrosis and Serum BankIdiopathic Pulmonary Fibrosis;Lung Diseases, InterstitialBiological: Blood sample collectionRennes University HospitalNULLRecruiting18 YearsN/AAll500France
328EUCTR2014-000963-42-DE
(EUCTR)
01/10/201413/08/2014A phase II study to assess vismodegib in the treatment of idiopathic pulmonary fibrosisA randomized, double-blind, placebo-controlled, phase II study to assess the efficacy and safety of oral vismodegib for the treatment of idiopathic pulmonary fibrosis - ISLAND Idiopathic pulmonary fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Erivedge
INN or Proposed INN: vismodegib
Other descriptive name: VISMODEGIB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Mexico;Spain;Peru;Australia;Israel;Chile;Germany;New Zealand;Italy;Korea, Republic of
329NCT02168530
(ClinicalTrials.gov)
October 201418/6/2014A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: placebo;Drug: vismodegibHoffmann-La RocheNULLWithdrawn40 YearsN/ABoth0Phase 2Australia;France;Germany;Israel;Korea, Republic of;Mexico;Peru;United States
330EUCTR2014-003423-21-BE
(EUCTR)
29/09/201429/08/2014Evaluation of impact of inhaled nitric oxide on pulmonary vessel blood volume measured by high resolution computed tomography (HRCT) in subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in subjects with WHO Group 3 Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) on Long-Term Oxygen Therapy (LTOT) (Part 2).An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic pulmonary fibrosis (IPF) on LTOT (Part 2). Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) Part 2: Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10009033;Term: Chronic obstructive pulmonary disease;Classification code 10037400;Term: Pulmonary hypertension;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: INOmax 400ppm mol/mol inhalation gas
Product Name: INO
INN or Proposed INN: NITRIC OXIDE
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
Phase 1;Phase 2Belgium
331NCT02257177
(ClinicalTrials.gov)
September 201429/9/2014RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF PatientsA Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Inhaled TD139;Drug: PlaceboGalecto Biotech ABNULLCompleted45 Years85 YearsAll60Phase 1/Phase 2United Kingdom
332NCT02268981
(ClinicalTrials.gov)
September 201417/9/2014Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDevice: Oxymizer® compared to CNCKlinikum Berchtesgadener Land der Schön-KlinikenNULLCompleted30 Years80 YearsBoth18N/AGermany
333NCT02173145
(ClinicalTrials.gov)
August 19, 201423/6/2014Azithromycin in Idiopathic Pulmonary FibrosisAzithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical TrialIdiopathic Pulmonary Fibrosis;CoughDrug: azithromycin;Drug: placeboUniversity Hospital Inselspital, BerneUniversity of BernCompleted18 YearsN/AAll27N/ASwitzerland
334NCT02135380
(ClinicalTrials.gov)
August 20148/5/2014Evaluate Safety and Efficacy of Intravenous Autologous ADMSc for Treatment of Idiopathic Pulmonary FibrosisA Prospective, Multicentric, Phase I/II, Open Label, Randomized, Interventional Study to Evaluate the Safety and Efficacy of Intravenous Autologous Adipose Derived Adult Stem Cells for Treatment of Idiopathic Pulmonary Fibrosis (IPF).Idiopathic Pulmonary FibrosisBiological: Autologous Stromal Vascular Fraction (SVF);Biological: Autologous Adipose Derived MSCs (ADMSCs);Other: ControlKasiak Research Pvt. Ltd.NULLRecruiting30 Years70 YearsBoth60Phase 1/Phase 2India
335NCT02248064
(ClinicalTrials.gov)
July 201412/9/2014Auto-titrating Oxygen in Chronic Respiratory FailureThe Assessment of Intelligent Oxygen Therapy (iO2t) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF)Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary FibrosisDevice: Auto-titrating oxygen systemImperial College LondonNULLCompleted18 YearsN/ABoth26N/AUnited Kingdom
336NCT02141087
(ClinicalTrials.gov)
July 201415/5/2014Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to PirfenidoneA Treatment Protocol to Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to PirfenidoneIdiopathic Pulmonary FibrosisDrug: PirfenidoneGenentech, Inc.NULLApproved for marketing18 YearsN/ABothN/ANULL
337NCT02622477
(ClinicalTrials.gov)
June 20142/12/2015Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPFIdiopathic Pulmonary FibrosisDrug: PirfenidoneHoffmann-La RocheInterMune Deutschland GmbHCompletedN/AN/AAll12N/AGermany
338EUCTR2013-004404-19-GB
(EUCTR)
07/05/201425/03/2014Effect of Fostair® on biomarkers of platelet adhesion in Idiopathic pulmonary fibrosisA Randomized, Double-blind, Placebo-controlled, Crossover Study toAssess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pulmonary fibrosis. - Effect of Fostair® pMDI on biomarkers of platelet adhesion in IPF Idiopathic pulmonary fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fostair
INN or Proposed INN: beclometasone dipropionate
INN or Proposed INN: formoterol fumarate dihydrate
Hull and East Yorkshire Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
339NCT02036970
(ClinicalTrials.gov)
May 201413/1/2014Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIATA Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary HypertensionPulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal FibroelastosisDrug: Bardoxolone methyl;Drug: PlaceboReata Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll166Phase 2United States;Germany;Spain;United Kingdom
340NCT02171156
(ClinicalTrials.gov)
May 201418/6/2014Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: nintedanibBoehringer IngelheimNULLApproved for marketing40 YearsN/AAllN/AUnited States
341EUCTR2013-001163-24-BE
(EUCTR)
28/04/201410/02/2014A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Trade Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
342NCT02085018
(ClinicalTrials.gov)
March 28, 20149/2/2014Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Omeprazole;Drug: Matched placeboNewcastle-upon-Tyne Hospitals NHS TrustNewcastle UniversityCompleted40 Years85 YearsAll45Phase 2United Kingdom
343NCT02048644
(ClinicalTrials.gov)
March 201423/1/2014Effect of Fostair® on Biomarkers of Platelet Adhesion in Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment With Fostair® Pressurized Metered-dose Inhaler (pMDI) 200/12 on Biomarkers of Platelet Adhesion in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: fostair;Drug: placeboHull University Teaching Hospitals NHS TrustChiesi Farmaceutici S.p.A.Completed40 Years85 YearsAll20Phase 2United Kingdom
344NCT02055456
(ClinicalTrials.gov)
February 20143/2/2014Nandrolone Decanoate in the Treatment of TelomeropathiesMale Hormones for Telomere Related DiseasesAplastic Anemia;Bone Marrow Failure Syndromes;Idiopathic Pulmonary Fibrosis;Telomere ShorteningDrug: Nandrolone DecanoateUniversity of Sao PauloConselho Nacional de Desenvolvimento Científico e TecnológicoRecruiting2 YearsN/ABoth20Phase 1/Phase 2Brazil
345NCT01969409
(ClinicalTrials.gov)
January 201417/10/2013Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary FibrosisAutoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis (ART-IPF)Ambulatory IPFDrug: Rituximab;Drug: PlaceboUniversity of Alabama at BirminghamNational Institutes of Health (NIH)Completed50 Years85 YearsAll58Phase 2United States
346NCT02036580
(ClinicalTrials.gov)
January 201413/1/2014D2212C00002 J-Phase II StudyA Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: tralokinumab cohort 1;Biological: tralokinumab cohort 2;Other: PlaceboAstraZenecaMedImmune LLCCompleted50 YearsN/AAll37Phase 2Japan
347NCT02009293
(ClinicalTrials.gov)
December 20131/12/2013The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary FibrosisObservational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisOther: Cough monitorErasmus Medical CenterUniversity of Catania;University of Lyon;King's College Hospital NHS Trust;Royal Brompton & Harefield NHS Foundation TrustCompleted40 Years85 YearsBoth43N/AFrance;Italy;Netherlands
348NCT01979952
(ClinicalTrials.gov)
November 26, 20134/11/2013Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen MonthsIdiopathic Pulmonary FibrosisDrug: Matching Placebo;Drug: NintedanibBoehringer IngelheimNULLCompleted40 YearsN/AAll113Phase 3United States;Canada;Turkey
349NCT01777737
(ClinicalTrials.gov)
November 25, 201325/1/2013Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With CotrimoxazolePilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Cotrimoxazole;Drug: PlaceboFundación Pública Andaluza para la gestión de la Investigación en SevillaJunta de AndaluciaTerminated18 Years80 YearsAll3Phase 3Spain
350EUCTR2013-001163-24-IT
(EUCTR)
19/11/201305/09/2013A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan
351NCT02013700
(ClinicalTrials.gov)
November 13, 20132/12/2013Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER)A Phase I, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs);Biological: matched placeboJoshua M HareThe Lester And Sue Smith Foundation;The Emmes Company, LLCTerminated40 Years90 YearsAll9Phase 1United States
352EUCTR2013-001163-24-PL
(EUCTR)
09/11/201301/10/2013A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Trade Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan
353EUCTR2013-001163-24-DE
(EUCTR)
04/11/201328/08/2013A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Trade Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
354JPRN-UMIN000021109
2013/10/2119/02/2016Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancerPreventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer - Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer (Sivelestat trial) idiopathic interstitial pneumonia (IIP)Control (n=30): intra- and postoperative management without Sivelestat
Trial (n=30): 7days administration of Sivelestat 0.2microgram/kgBW/hr div started from surgical operation
Japanese Northern East Area Thoracic Surgery Study Group (JNETS)NULLComplete: follow-up complete25years-old80years-oldMale and Female120Phase 3Japan
355EUCTR2013-001163-24-GB
(EUCTR)
14/10/201306/11/2013A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Trade Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
356NCT01872689
(ClinicalTrials.gov)
October 13, 20135/6/2013A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Lebrikizumab;Drug: Pirfenidone;Drug: PlaceboHoffmann-La RocheNULLCompleted40 YearsN/AAll505Phase 2United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Mexico;Peru;Poland;Spain;United Kingdom
357EUCTR2013-003301-26-GB
(EUCTR)
20/09/201304/11/2013A clinical trial to assess whether a treatment reducing acid production in the stomach (omeprazole) can reduce cough in patients with scarring of the lungs.A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF) - Pilot trial of omeprazole in idiopathic pulmonary fibrosis (Acronym : Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Omeprazole (UK licensed generic product)
Product Name: Omeprazole
INN or Proposed INN: Omeprazole
Newcastle Upon Tyne Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
358EUCTR2013-001163-24-ES
(EUCTR)
20/09/201316/09/2013A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Peru;Australia;Germany;Japan
359EUCTR2013-001163-24-FR
(EUCTR)
17/09/201328/09/2015A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan
360EUCTR2012-000564-14-GB
(EUCTR)
11/09/201304/07/2013 A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
361EUCTR2012-001571-36-PL
(EUCTR)
09/09/201317/06/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Spain;Belgium;Poland;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
362EUCTR2012-000564-14-DK
(EUCTR)
28/08/201312/07/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
363NCT02707640
(ClinicalTrials.gov)
August 20139/3/2016A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of PirfenidoneIdiopathic Pulmonary FibrosisDrug: Matching Placebo;Drug: N-acetylcysteine;Drug: PirfenidoneHoffmann-La RocheNULLCompleted40 Years80 YearsAll123Phase 2Austria;Belgium;Denmark;France;Germany;Italy;Sweden;United Kingdom
364NCT01890265
(ClinicalTrials.gov)
July 30, 201324/6/2013Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: Placebo;Drug: Sub-Study: Pirfenidone;Drug: Sub-Study: NintedanibFibroGenNULLCompleted40 Years80 YearsAll160Phase 2United States;Australia;Bulgaria;Canada;India;New Zealand;South Africa
365EUCTR2012-000564-14-AT
(EUCTR)
19/07/201311/06/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Sweden;Italy;United Kingdom;Germany;Austria;Denmark;Belgium
366EUCTR2012-000564-14-DE
(EUCTR)
17/07/201329/05/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
367EUCTR2012-000564-14-IT
(EUCTR)
17/07/201307/06/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
368EUCTR2012-000564-14-SE
(EUCTR)
25/06/201324/05/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
369EUCTR2012-000564-14-BE
(EUCTR)
18/06/201330/04/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
370EUCTR2012-001571-36-DE
(EUCTR)
17/06/201302/04/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
371EUCTR2012-001571-36-BE
(EUCTR)
28/05/201326/03/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2Korea, Democratic People's Republic of;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Korea, Republic of;United States;Spain
372EUCTR2012-001571-36-ES
(EUCTR)
12/05/201316/05/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINER Idiopathic pulmonary fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Belgium;Spain;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
373EUCTR2012-001571-36-CZ
(EUCTR)
29/04/201315/04/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
374EUCTR2012-001571-36-IT
(EUCTR)
26/04/201328/02/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
375EUCTR2011-002766-21-IE
(EUCTR)
23/04/201315/02/2013Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
376EUCTR2012-005409-38-ES
(EUCTR)
19/04/201329/01/2013First study to test the validity of the treatment of the disease called idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with a drug called cotrimoxazole.Pilot study phase III to evaluate the efficacy and safety of Trimethoprim-sulfamethoxazole in the treatment of idiopathic pulmonary fibrosis Ambulatory patients, men and women, with well-established diagnosis of idiopathic pulmonary fibrosis.
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Parasitic Diseases [C03]
Trade Name: SEPTRIN
INN or Proposed INN: TRIMETHOPRIM
Other descriptive name: TRIMETHOPRIM
INN or Proposed INN: SULFAMETHOXAZOLE
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)NULLNot RecruitingFemale: yes
Male: yes
56Phase 3Spain
377EUCTR2012-001571-36-GB
(EUCTR)
19/04/201328/03/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;Italy;United Kingdom;Korea, Republic of
378EUCTR2012-005794-31-GB
(EUCTR)
25/03/201326/02/2013A study to assess the effect of a single-does of VRP700 by inhalation to reduce the frequency and severity of cough in adults with Idiopathic Pulmonary Fibrosis (IPF)A randomised, double-blind, placebo-controlled crossover study to assess the efficacy of a single dose of 100mg of VRP700 by inhalation in reducing the frequency and severity of cough in adult patients with Idiopathic Pulmonary Fibrosis - EPOCh Chronic cough in Idiopathic Pulmonary Fibrosis
MedDRA version: 16.1;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.1;Level: PT;Classification code 10011224;Term: Cough;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VRP700
Product Code: VRP700
Verona Pharma plcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
379NCT01725139
(ClinicalTrials.gov)
March 8, 20138/11/2012A Proof of Mechanism Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomised, Placebo-controlled, Double-blind, Repeat Dose Escalation Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: GSK2126458;Drug: PlaceboGlaxoSmithKlineNULLCompleted45 YearsN/AAll17Phase 1United Kingdom
380NCT01919827
(ClinicalTrials.gov)
March 20131/8/2013Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary FibrosisTreatment of Idiopathic Pulmonary Fibrosis With Bone Marrow Derived Mesenchymal Stem CellsIdiopathic Pulmonary FibrosisBiological: Endobronchial infusion of adult mesenchymal stem cells;Biological: Autologous mesenchymal stem cells derived from bone marrowClinica Universidad de Navarra, Universidad de NavarraNULLCompleted30 Years80 YearsAll17Phase 1Spain
381NCT02594839
(ClinicalTrials.gov)
February 20131/11/2015Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung DiseaseA Phase I-II Study to Evaluate Safety and Efficacy of Allogeneic Bone-Marrow Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung DiseaseIdiopathic Interstitial Pneumonia;Interstitial Lung Disease;Idiopathic Pulmonary FibrosisDrug: Bone marrow mesenchymal stem cells;Drug: PlaceboFederal Research Clinical Center of Federal Medical & Biological Agency, RussiaNULLCompleted20 Years80 YearsAll20Phase 1/Phase 2Russian Federation
382NCT01769196
(ClinicalTrials.gov)
January 31, 201314/1/2013Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Simtuzumab;Drug: Simtuzumab placeboGilead SciencesNULLTerminated45 Years85 YearsAll544Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Poland;Spain;Switzerland;United Kingdom;Czech Republic
383NCT01766817
(ClinicalTrials.gov)
January 31, 201310/1/2013Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary FibrosisSafety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BMS-986020;Drug: Placebo matching with BMS-986020Bristol-Myers SquibbNULLCompleted40 Years90 YearsAll325Phase 2United States;Australia;Chile;Colombia;Mexico;Peru
384JPRN-jRCTs051180149
24/01/201320/03/2019CBDCA plus PTX for NSCLC (squamous) with IPPhase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia - IP001 Squamous cell lung cancer
Lung cancer
Carboplatin (AUC=5) given on day1 and paclitaxel (70mg/m2) given on days 1,8,15 every 4weeks until disease progression or unmanageable toxicity.Katakami NobuyukiNULLComplete>= 20age oldNot applicableBoth40Phase 2Japan
385JPRN-jRCTs061180046
17/01/201312/03/2019CBDCA, PTX and BV for NSCLC (non-sq) with IPPhase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia - IP002 Non-squamous, non-small cell lung cancer
Lung cancer
Carboplatin (AUC=5) given on day1, paclitaxel (70mg/m2) given on days 1,8,15 and bevacizumab (15mg/m2) on day 1 every 4weeks until disease progression or unmanageable toxicity.Katakami NobuyukiNULLComplete>= 20age oldNot applicableBoth35Phase 2Japan
386JPRN-UMIN000016706
2013/01/0704/03/2015Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosisN-acetylcysteine was administered by inhalation at the dose of 352.4 mg b.i.d. via an ultrasonic nebulizer.Saitama Red Cross HospitalNULLComplete: follow-up complete40years-oldNot applicableMale and Female25Not selectedJapan
387JPRN-UMIN000018248
2012/12/0109/07/2015Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia advanced squamous cell lung cancer with idiopathic interstitial pneumoniaCarboplatin AUC = 5 , day1
Paclitaxel 70mg/m2, day1,8,15
4-6 cycle
IP lung cancer study groupNULLRecruiting20years-oldNot applicableMale and Female40Phase 2Japan
388JPRN-UMIN000018322
2012/12/0115/07/2015Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumoniacarboplatin AUC = 5, day1
paclitaxel 70mg/m2, day1 ,8 ,15
bevacizumab 15mg/kg, day1
every 4 weeks, 4-6 cycle
IP lung cancer study groupNULLRecruiting20years-oldNot applicableMale and Female35Phase 2Japan
389NCT01759511
(ClinicalTrials.gov)
October 18, 201215/11/2012Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: SimtuzumabGilead SciencesNULLTerminated18 YearsN/AAll34Phase 2United States
390NCT01629667
(ClinicalTrials.gov)
October 201212/6/2012A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary FibrosisA Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: Tralokinumab;Other: PlaceboMedImmune LLCNULLTerminated50 Years79 YearsAll409Phase 2United States;Australia;Canada;Israel;Korea, Republic of;Peru
391NCT01524068
(ClinicalTrials.gov)
September 201227/1/2012A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis ExacerbationsA Multicenter, Open-Label, Phase II Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis ExacerbationsIdiopathic Pulmonary FibrosisDrug: Standard Steroid Treatment;Drug: The Standard Steroid Treatment, Plasma Exchange and rituximabUniversity of PittsburghNULLWithdrawn18 Years90 YearsBoth0Phase 2United States
392EUCTR2011-002766-21-CZ
(EUCTR)
03/08/201219/06/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
393JPRN-UMIN000008541
2012/07/3030/07/2012The effect of pirfenidone on the mortality risk score in IPF idiopathic pulmonary fibrosispirfenidoneDepartment of Respiratory Medicine and Allergology, Kinki University Faculty of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not applicableJapan
394EUCTR2011-002766-21-IT
(EUCTR)
25/07/201219/06/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Chile;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;China;Japan;Korea, Republic of
395NCT01371305
(ClinicalTrials.gov)
July 16, 20123/6/2011STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)Drug: BG00011;Drug: PlaceboBiogenNULLCompleted18 Years84 YearsAll41Phase 2United States
396EUCTR2011-002766-21-DE
(EUCTR)
02/07/201204/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
397EUCTR2011-002766-21-BE
(EUCTR)
26/06/201226/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
SCS Boehringer Ingelheim Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
398EUCTR2011-002766-21-ES
(EUCTR)
18/06/201226/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim España S.ANULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
399EUCTR2011-002766-21-GB
(EUCTR)
15/06/201221/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) - Idiopathic Pulmonary Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
400NCT01619085
(ClinicalTrials.gov)
June 6, 20126/6/2012Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary FibrosisAn Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: BIBF 1120Boehringer IngelheimNULLActive, not recruiting40 YearsN/AAll752Phase 3United States;Australia;Belgium;Canada;Chile;China;Czechia;Finland;France;Germany;Greece;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Czech Republic
401EUCTR2011-002766-21-FI
(EUCTR)
06/06/201216/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
402JPRN-UMIN000007774
2012/06/0116/04/2012Phase II analysis for efficacy and safety of perioperative pirfenidone (Pirespa) therapy for patients with non-small cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) non-small-cell lung cancer combined with idiopathic pulmonary fibrosisOral administration of pirfenidone starting from 4-6 weeks before the surgery.West Japan Oncology GroupNULLComplete: follow-up complete20years-old75years-oldMale and Female42Phase 2Japan
403EUCTR2011-002766-21-GR
(EUCTR)
02/05/201211/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim HellasNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
404EUCTR2011-002766-21-PT
(EUCTR)
20/04/201220/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Unilfarma - União Internacional de Lab. Farmacêuticos, LdaNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
405NCT01529853
(ClinicalTrials.gov)
April 20126/2/2012To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Repeated Doses of SAR156597 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: SAR156597;Drug: PlaceboSanofiNULLCompleted18 YearsN/ABoth24Phase 1/Phase 2United States;Canada;Chile;Mexico;Spain;Belgium
406NCT01457261
(ClinicalTrials.gov)
April 201219/10/2011IPF Drug Deposition StudyA Study of the Pharmacokinetics and Deposition of Inhaled Salbutamol in Patients With Idiopathic Pulmonary Fibrosis (TOPICAL-IPF)Idiopathic Pulmonary FibrosisDrug: SalbutamolRoyal Brompton & Harefield NHS Foundation TrustGlaxoSmithKlineCompleted40 YearsN/ABoth10Phase 1United Kingdom
407EUCTR2011-003687-78-IT
(EUCTR)
21/02/201205/03/2012Lanreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF)Lanreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF) - IPF/LANREOTIDE/2011-01 Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
INN or Proposed INN: LANREOTIDE ACETATE
Product Name: Gallium68-Dota-Noc
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: NA
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
408NCT02699879
(ClinicalTrials.gov)
February 16, 201226/2/2016Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World SettingIdiopathic Pulmonary FibrosisDrug: PirfenidoneHoffmann-La RocheNULLCompletedN/AN/AAll1009N/AAustria;Denmark;Finland;France;Germany;Ireland;Italy;Norway;Sweden;United Kingdom
409NCT01504334
(ClinicalTrials.gov)
January 201230/12/2011Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF)A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for the Safety and Efficacy of Pirfenidone in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: PlaceboBeijing Kawin Technology Share-Holding Co., Ltd.NULLRecruiting18 Years75 YearsBoth80Phase 2China
410NCT02136992
(ClinicalTrials.gov)
December 201111/5/2014Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: placeboShanghai Pulmonary Hospital, Shanghai, ChinaNanjing Chia-tai Tianqing PharmaceuticalCompletedN/A75 YearsBoth160Phase 2NULL
411NCT01462006
(ClinicalTrials.gov)
October 201126/10/2011Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)Double-blind Placebo-controlled Pilot Study of Sirolimus in IPFIdiopathic Pulmonary Fibrosis;Diffuse Parenchymal Lung Disease;Interstitial Lung DiseaseDrug: sirolimus;Other: PlaceboUniversity of VirginiaNational Heart, Lung, and Blood Institute (NHLBI)Completed21 Years85 YearsAll32N/AUnited States
412NCT01382368
(ClinicalTrials.gov)
September 20112/5/2011Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy PatientsAcute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy PatientsChronic Obstructive Pulmonary Disease;Idiopathic Pulmonary FibrosisDrug: SildenafilRabin Medical CenterNULLEnrolling by invitation30 Years90 YearsBoth60Phase 4Israel
413NCT01432080
(ClinicalTrials.gov)
September 20118/9/2011Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post AllotransplantDoes Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot StudyRespiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, InterstitialDrug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: SymbicortMaisonneuve-Rosemont HospitalThe Canadian Blood and Marrow Transplant GroupTerminated18 YearsN/AAll12Phase 2Canada
414NCT01417156
(ClinicalTrials.gov)
September 201115/8/2011Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary FibrosisPulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneoneBoehringer IngelheimNULLCompleted40 YearsN/AAll20Phase 2Japan
415EUCTR2010-024211-13-DE
(EUCTR)
20/07/201112/04/2011Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC studyLong term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL Patients with Idiopathic Pulmonary Fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
ACTELION Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
178Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel
416NCT01214187
(ClinicalTrials.gov)
July 201130/9/2010Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary FibrosisPhase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: inhaled carbon monoxide;Other: OxygenBrigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI);University of California, San Francisco;University of Chicago;University of Illinois at Chicago;University of Michigan;Columbia University;Tulane University;University of WashingtonCompleted18 Years85 YearsAll58Phase 2United States
417NCT01346930
(ClinicalTrials.gov)
July 20112/5/2011Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary FibrosisLong Term, Single-arm, Open-label Extension Study of the MUSIC Study to Assess the Safety and Tolerability of Macitentan in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: MacitentanActelionNULLWithdrawn18 YearsN/ABoth0Phase 2NULL
418EUCTR2010-020688-18-GB
(EUCTR)
29/06/201128/01/2011Safety and Efficacy of QAX576 in Patients With Progressive Idiopathic Pulmonary Fibrosis (IPF)A randomized, double-blind, placebo-controlled, multipledose, exploratory proof of concept study to assess the safety, tolerability, efficacy, pharmacodynamics andpharmacokinetics of QAX576 in patients with rapidly progressive idiopathic pulmonary fibrosis Patients with rapidly progressive idiopathic pulmonary fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Code: QAX576Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom
419EUCTR2010-024211-13-ES
(EUCTR)
27/06/201110/11/2011Study to evaluate if macitentan is safe and tolerable enough to be usedfor treatment of idiopathic pulmonary fibrosis, following the MUSICstudyLong term, single-arm, open-label extension study of the MUSIC study toassess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL Patients with Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel
420EUCTR2010-024252-29-NL
(EUCTR)
16/06/201111/05/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Germany;Netherlands
421EUCTR2010-024211-13-SI
(EUCTR)
13/06/201111/07/2011Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC studyLong term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL Patients with Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178United States;Slovenia;Canada;Spain;Turkey;Australia;Israel;South Africa;Germany;Sweden
422EUCTR2010-023828-24-GB
(EUCTR)
09/06/201127/04/2011The effect of Thalidomide on sputum biomarkers in IPF cough. - The effect of Thalidomide on sputum biomarkers in IPF coughThe effect of Thalidomide on sputum biomarkers in IPF cough. - The effect of Thalidomide on sputum biomarkers in IPF cough Cough in Idiopathic Pulmonary fibrosis.Trade Name: Thalidomide Pharmion
Product Name: Thalidomide Pharmion
Trade Name: PREDNISOLONE
Product Name: prednisolone
University of NottinghamNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
423NCT01366209
(ClinicalTrials.gov)
June 20112/6/2011Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)Idiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: PlaceboGenentech, Inc.NULLCompleted40 Years80 YearsAll555Phase 3United States
424EUCTR2010-024211-13-SE
(EUCTR)
26/05/201105/04/2011Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC studyLong term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL Patients with Idiopathic Pulmonary Fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178Germany;Canada;Turkey;Spain;United States;South Africa;Australia;Sweden;Israel
425EUCTR2010-024252-29-ES
(EUCTR)
25/05/201103/11/2011-A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: BIBF1120
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: BIBF1120
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
485Phase 3United States;Portugal;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Germany;Netherlands;China;Japan;Korea, Republic of
426EUCTR2010-024251-87-BE
(EUCTR)
18/05/201117/03/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
485Phase 3United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China
427EUCTR2010-024252-29-PT
(EUCTR)
13/05/201116/02/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
485China;Japan;Korea, Republic of;United States;Portugal;Greece;Finland;Spain;Russian Federation;India;France;Mexico;Canada;Germany;Netherlands
428EUCTR2010-024251-87-IE
(EUCTR)
11/05/201123/03/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
485Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom
429EUCTR2010-024251-87-IT
(EUCTR)
10/05/201119/09/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BIBF 1120
Product Code: BIBF 1120
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
646Czech Republic;Belgium;Ireland;Germany;United Kingdom;Italy
430EUCTR2010-024252-29-GR
(EUCTR)
02/05/201104/04/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Netherlands;Germany
431NCT01335477
(ClinicalTrials.gov)
May 201113/4/2011Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients IIA 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Pulmonary FibrosisDrug: placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll551Phase 3United States;Canada;Chile;China;Finland;France;Germany;Greece;India;Japan;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;Spain;Turkey
432EUCTR2010-024251-87-GB
(EUCTR)
28/04/201124/02/2011Safety and efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
485Phase 3Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom
433EUCTR2010-024251-87-CZ
(EUCTR)
26/04/201108/04/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim RCV GmBH & Co KGNULLNot RecruitingFemale: yes
Male: yes
485India;Czech Republic;Argentina;Brazil;Belgium;Australia;Germany;China;Japan;United States;Ireland;Israel;Italy;United Kingdom
434EUCTR2010-024251-87-DE
(EUCTR)
12/04/201109/02/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
485United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;China;Japan;Germany;Australia
435EUCTR2010-024252-29-DE
(EUCTR)
07/04/201109/02/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
485Portugal;United States;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Netherlands;Germany;Japan;China;Korea, Republic of
436EUCTR2010-024252-29-FI
(EUCTR)
01/04/201104/02/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Netherlands;Germany
437NCT01335464
(ClinicalTrials.gov)
April 201113/4/2011Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis PatientsA 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Pulmonary FibrosisDrug: placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll515Phase 3United States;Australia;Belgium;China;Czech Republic;France;Germany;India;Ireland;Israel;Italy;Japan;United Kingdom;Argentina;Brazil
438NCT01265888
(ClinicalTrials.gov)
March 201120/12/2010Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl.A Phase 2, Open-Label, Dose-Escalation Study in Subjects With Pulmonary Arterial Hypertension, (PAH, WHO Group 1) and Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis, (PH-IPF WHO Group 3) Using Inhaled GeNOsyl.Pulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: Inhaled Nitric OxideGeno LLCNULLCompleted18 Years80 YearsBoth31Phase 2United States
439NCT01262001
(ClinicalTrials.gov)
March 201115/12/2010Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary FibrosisA Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: FG-3019FibroGenNULLCompleted35 Years80 YearsAll90Phase 2United States
440NCT01266317
(ClinicalTrials.gov)
March 201122/12/2010Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis ExacerbationsOpen-Label, Feasibility Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis ExacerbationsIPFDrug: Combined Plasma Exchange (PEX), Rituximab, and CorticosteroidsMichael DonahoeNULLCompleted18 Years80 YearsAll9Phase 1/Phase 2United States
441ChiCTR-TRC-12002372
2011-02-232012-07-15Levofloxacin (Cravit) versus Moxifloxacin-concentration of epithelial lining fluid in patients with idiopathic pulmonary fibrosis (IPF)Levofloxacin (Cravit) versus Moxifloxacin-concentration of epithelial lining fluid in patients with idiopathic pulmonary fibrosis idiopathic pulmonary fibrosisCravit IPF Group:Cravit 500 mg per time;Cravit Normal Pulmonary Function Group:Cravit 500 mg per time;Moxifloxacin IPF Group:Moxifloxacin 400mg per time;Moxifloxacin Normal PulmonaryFunction Group:Moxifloxacin 400mg per time;Respiratory Department, Peking Union Medical College HospitalNULLCompleted1870BothCravit IPF Group:12;Cravit Normal Pulmonary Function Group:12;Moxifloxacin IPF Group:12;Moxifloxacin Normal PulmonaryFunction Group:12;China
442JPRN-UMIN000005098
2011/02/0118/02/2011A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia idiopathic pulmonary fibrosisambulatory oxygen
ambulatory air
Department of Respiratory Medicine and Allergology, Kinki University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
443EUCTR2009-011169-98-CZ
(EUCTR)
10/01/201129/11/2010ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.1;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 3United Kingdom;Germany;Czech Republic;Italy;Austria
444NCT01203943
(ClinicalTrials.gov)
January 1, 201115/9/2010A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis;Pulmonary Fibrosis;Fibrosis;Interstitial Lung Disease;Lung Diseases, InterstitialDrug: CC-930;Other: PlaceboCelgeneNULLTerminated50 YearsN/AAll28Phase 2United States;Canada
445JPRN-UMIN000004749
2011/01/0118/12/2010A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. Patients with COPD or IPF (WHO functional class II, III or IV), without hypoxia (PaO2 at rest<90mmHg or after 6minutes walk), who provide their informed consent to participate in this study.Treated subgroup
In patients with COPD without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with Pulmonary hypertension with evidense of mPAP at rest=/>35mmHg : 20subjects
Bosentan will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition.
Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice daily to be taken orally after breakfast and the evening meal for 4 weeks. From Week 5 of treatment, bosentan is administered at a dose of 125 mg twice daily to be taken orally after breakfast and evening meal. The dosage should be adjusted according to the patient's symptoms and tolerability, but should not exceed 250 mg per day.
Duration of study drug administration: 24 months

In addition, Interventions/Control 11 and 12 is described in Interventions/control 10.
Treated subgroup
In patients with COPD without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with boarderline pulmonary hypertension or pulmonary hypertension (mPAP at rest=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<35mmHg: 20subjects
Tracleer Tablets will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition.
Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice daily to be taken orally after breakfast and the evening meal for 4 weeks. From Week 5 of treatment, bosentan is administered at a dose of 125 mg twice daily to be taken orally after breakfast and even
Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical SchoolNULLRecruiting40years-oldNot applicableMale and Female160Not applicableJapan
446NCT01254409
(ClinicalTrials.gov)
January 20113/12/2010A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: PRM-151;Other: PlaceboHoffmann-La RocheNULLCompleted40 Years80 YearsAll21Phase 1United States;Netherlands
447NCT01266135
(ClinicalTrials.gov)
December 201017/12/2010Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPFIdiopathic Pulmonary FibrosisDrug: QAX576;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years80 YearsAll40Phase 2United States;United Kingdom
448NCT01362231
(ClinicalTrials.gov)
December 201012/4/2011A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary FibrosisA Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GS-6624Gilead SciencesNULLCompleted40 Years85 YearsBoth48Phase 1United States
449EUCTR2009-013788-21-BG
(EUCTR)
05/10/201018/08/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim RCV GmBH & Co KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
450EUCTR2008-004405-34-CZ
(EUCTR)
13/09/201007/01/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
451NCT01199887
(ClinicalTrials.gov)
September 20109/9/2010Trial Of IW001 in Patients With Idiopathic Pulmonary FibrosisA Phase One, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: IW001ImmuneWorksNULLCompleted35 Years75 YearsBoth30Phase 1United States
452EUCTR2009-013788-21-IE
(EUCTR)
05/08/201020/05/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LtdNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
453EUCTR2010-020223-44-AT
(EUCTR)
03/08/201029/06/2010(18)F-FDG PET/CT in patients with idiopathic interstitial pneumonias: correlation of tracer uptake and histological findings, and texture-based recognition of usual interstitial pneumonia(18)F-FDG PET/CT in patients with idiopathic interstitial pneumonias: correlation of tracer uptake and histological findings, and texture-based recognition of usual interstitial pneumonia Interstitial lung disease of unknown etiologyTrade Name: (18)F-FDG
Product Name: (18)F-FDG
INN or Proposed INN: FLUORINE (18F) FLUDEOXYGLUCOSE
Medizinische Universität Wien, Univ.Klinik f.RadiodiagnostikNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
454EUCTR2009-013788-21-CZ
(EUCTR)
02/08/201028/07/2010study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary FibrosisA phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;Greece;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany
455EUCTR2008-001281-86-DE
(EUCTR)
02/08/201016/03/2010A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary FibrosisA Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: CNTO888
Product Code: CNTO888
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Germany;Netherlands;Belgium
456EUCTR2009-013788-21-GR
(EUCTR)
14/07/201015/11/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Ellas AENULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
457NCT01170065
(ClinicalTrials.gov)
June 25, 20106/7/2010Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary FibrosisPulmonary FibrosisDrug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll198Phase 2Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Ireland;Italy;Mexico;Netherlands;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;El Salvador
458EUCTR2009-013788-21-HU
(EUCTR)
16/06/201005/07/2010A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary FibrosisA phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Boehringer Ingelheim RCV GmBH & Co KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
459EUCTR2009-013788-21-GB
(EUCTR)
04/06/201011/10/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Italy;United Kingdom
460NCT01135199
(ClinicalTrials.gov)
June 201028/5/2010Pomalidomide for Cough in Patients With Idiopathic Pulmonary FibrosisSafety and Efficacy of Pomalidomide in the Treatment of Refractory Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): A Pilot StudyPulmonary FibrosisDrug: pomalidomide (CC-4047Stanford UniversityCelgene CorporationWithdrawn18 YearsN/ABoth0Phase 2United States
461EUCTR2009-013788-21-DE
(EUCTR)
27/05/201022/04/2010Roll over study from 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;Greece;Spain;Ireland;Russian Federation;Chile;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;China;Korea, Republic of
462EUCTR2009-013788-21-PT
(EUCTR)
10/05/201018/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Unilfarma, Lda.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;Portugal;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
463NCT01136174
(ClinicalTrials.gov)
May 201031/5/2010Safety and PK Study of BIBF 1120 in Japanese Patients With IPFA Double-blind, Randomised, Placebo-controlled (Within a Dose Group) Study to Evaluate Safety and Pharmacokinetics of Multiple Rising Doses of BIBF 1120 at 50 mg Bid (14 Days), 100 mg Bid (14 Days), and 150 mg Bid (28 Days) p.o., on Top of Standard Medical Care With Stratification According to Pirfenidone Use, in Japanese Patients With Idiopathic Pulmonary Fibrosis.Idiopathic Pulmonary FibrosisDrug: Placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll50Phase 2Japan
464EUCTR2009-013788-21-ES
(EUCTR)
28/04/201023/02/2010Ensayo clínico de Fase II, abierto, y de extensión para evaluar la tolerabilidad a largo plazo, la seguridad y la eficacia de BIBF 1120 administrado por vía oral en pacientes con Fibrosis Pulmonar IdiopáticaA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisEnsayo clínico de Fase II, abierto, y de extensión para evaluar la tolerabilidad a largo plazo, la seguridad y la eficacia de BIBF 1120 administrado por vía oral en pacientes con Fibrosis Pulmonar IdiopáticaA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Fibrosis Pulmonar Idiopática
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim España S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
465EUCTR2009-013788-21-BE
(EUCTR)
22/04/201008/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;United Kingdom;Italy
466EUCTR2009-013788-21-FR
(EUCTR)
09/04/201008/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
467EUCTR2009-013788-21-IT
(EUCTR)
07/04/201026/03/2010A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis - NDA phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis - ND Idiopathic Pulmonary Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10021240
Product Code: BIBF 1120
Product Code: BIBF 1120
Product Code: BIBF 1120
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
468EUCTR2008-006054-17-IT
(EUCTR)
26/01/201022/10/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSICA double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC Idiopathic Pulmonary Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10021240
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Actelion Pharamceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
469EUCTR2009-011169-98-AT
(EUCTR)
26/11/200925/08/2009ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
470EUCTR2009-011169-98-DE
(EUCTR)
03/11/200906/08/2009ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
471JPRN-UMIN000005793
2009/11/0116/06/2011Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema Idiopathic pulmonary fibrosis (IPF) with centrilobular emphysema (CLE)tiotropium for 8 weeks and then
tiotropium + pirfenidone for 44 weeks
pirfenidone 44 weeks and then
tiotropium + pirfenidone for 8 weeks
Saitama Medical UniversityNULLRecruiting40years-oldNot applicableMale and Female60Not selectedJapan
472EUCTR2009-011169-98-GB
(EUCTR)
30/10/200901/09/2009ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;Germany;United Kingdom;Italy;Austria
473JPRN-UMIN000016045
2009/10/0326/12/2014A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosisUsing Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks.
Pirfenidone 1200-1800mg (control group)
Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,NULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
474NCT00957242
(ClinicalTrials.gov)
October 200910/8/2009AntiCoagulant Effectiveness in Idiopathic Pulmonary FibrosisAntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)Idiopathic Pulmonary FibrosisDrug: warfarin;Drug: placeboDuke UniversityNational Heart, Lung, and Blood Institute (NHLBI);Duke Clinical Research InstituteTerminated35 Years80 YearsAll145Phase 3United States
475EUCTR2009-011169-98-IT
(EUCTR)
22/09/200921/09/2009A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - NDA Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ND Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10021240
MedDRA version: 9.1;Classification code 10037400
Trade Name: Letairis
Trade Name: Letairis
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
476EUCTR2008-004405-34-IE
(EUCTR)
08/09/200907/01/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMISA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
477NCT00981747
(ClinicalTrials.gov)
September 200919/9/2009Targeting Vascular Reactivity in Idiopathic Pulmonary FibrosisA Clinical Treatment Trial Targeting Vascular Reactivity in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Pulmonary FibrosisDrug: Sildenafil;Drug: Losartan;Drug: Sildenafil and Losartan;Drug: Placebo Oral TabletAlicia GerkePulmonary Fibrosis FoundationTerminated18 Years99 YearsAll12Phase 2/Phase 3United States
478EUCTR2008-006054-17-SE
(EUCTR)
12/08/200925/06/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSICA double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
479EUCTR2008-004405-34-IT
(EUCTR)
03/08/200927/07/2009A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFA Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: VOLIBRIS
INN or Proposed INN: Ambrisentan
Trade Name: VOLIBRIS
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
480NCT00879229
(ClinicalTrials.gov)
July 20098/4/2009ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary FibrosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Idiopathic Pulmonary Fibrosis and Pulmonary HypertensionIdiopathic Pulmonary Fibrosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboGilead SciencesNULLTerminated35 Years80 YearsAll40Phase 3United States;Australia;Austria;Canada;Germany;Italy;United Kingdom;Belgium;Ireland;Israel
481EUCTR2008-004405-34-GB
(EUCTR)
08/06/200928/04/2009ARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
482EUCTR2008-004405-34-NL
(EUCTR)
04/06/200910/03/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
483JPRN-UMIN000007663
2009/06/0105/04/2012Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF).Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF). - Efficacy of inhaled NAC in IPF. Idiopathic pulmonary fibrosisinhaled NAC mono-therapyToho University Omori Medical CenterDepartment of Respiratory Med