Inhaled Treprostinil ( DrugBank: Treprostinil )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
84サルコイドーシス1
85特発性間質性肺炎5
86肺動脈性肺高血圧症19

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03814317
(ClinicalTrials.gov)
January 30, 20204/1/2019Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary HypertensionAn Open-Label Study of Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension and Interstitial Lung Disease (SAPPHIRE)Sarcoidosis;Precapillary Pulmonary Hypertension;Interstitial Lung DiseaseDrug: Inhaled TreprostinilUniversity of FloridaUnited TherapeuticsRecruiting18 Years99 YearsAll10Phase 2United States

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05255991
(ClinicalTrials.gov)
October 4, 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 TherapeuticsNULLRecruiting40 YearsN/AAll396Phase 3Argentina;Australia;Chile;Denmark;France;Israel;Korea, Republic of;Mexico;Spain;Taiwan
2EUCTR2021-005881-17-DK
(EUCTR)
12/09/202215/07/2022A study evaluating the 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
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: TYVASO® (treprostinil) inhalation solution, for oral inhalation use
Product Name: Treprostinil
INN or Proposed INN: Treprostinil
UNITED THERAPEUTICS CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
396Phase 3Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Denmark;Australia;Peru;Germany;Netherlands;New Zealand;Korea, Republic of
3NCT04905693
(ClinicalTrials.gov)
September 6, 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 TherapeuticsNULLEnrolling by invitation40 YearsN/AAll792Phase 3United States
4NCT04708782
(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
5NCT00703339
(ClinicalTrials.gov)
June 200819/6/2008Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary FibrosisA Single-Dose, Dose-Escalating Study Exploring the Safety, Pharmacokinetics, and Pharmacodynamic Effects of Inhaled Treprostinil Sodium Using the Nebu-Tec OPTINEB Inhalation Device in Patients With Pulmonary Hypertension Associated With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Pulmonary HypertensionDrug: Treprostinil sodium for inhalationLung Biotechnology PBCNULLTerminated35 Years80 YearsAll1Phase 2United States

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05564637
(ClinicalTrials.gov)
February 202328/9/2022A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary HypertensionComprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary HypertensionPulmonary Arterial Hypertension;Interstitial Lung Disease;Healthy AdultsDrug: Treprostinil;Diagnostic Test: Right Heart Catheterization (RHC) while exercising;Diagnostic Test: Optional Muscle BiopsyMayo ClinicUnited TherapeuticsRecruiting18 YearsN/AAll18Phase 2United States
2NCT03992755
(ClinicalTrials.gov)
July 18, 20195/6/2019Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of TreprostinilA Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Active, not recruiting18 YearsN/AAll92Phase 3United States
3EUCTR2018-003414-40-DE
(EUCTR)
31/01/201906/11/2018A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension PatientsA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects Pulmonary Arterial Hypertension (WHO Group 1)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: LIQ861 26.5 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 53 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 79.5 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 106 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: Nitric Oxide
INN or Proposed INN: NITRIC OXIDE
Liquidia Technologies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2France;Germany
4EUCTR2018-003414-40-FR
(EUCTR)
21/01/201906/11/2018A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension PatientsA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects Pulmonary Arterial Hypertension (WHO Group 1)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: LIQ861 25 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 50 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 75 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 100 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Liquidia Technologies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2France;Germany
5NCT03399604
(ClinicalTrials.gov)
January 2, 20183/1/2018Investigation of the Safety and Pharmacology of Dry Powder Inhalation of TreprostinilA Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Completed18 YearsN/AAll121Phase 3United States
6NCT02471183
(ClinicalTrials.gov)
November 4, 201511/6/2015Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial HypertensionMulticenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SelexipagActelionNULLCompleted18 Years75 YearsAll30Phase 3United States
7NCT01557660
(ClinicalTrials.gov)
June 201214/3/2012Inhaled Treprostinil for PAH: Open-label ExtensionInhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center StudyPulmonary Arterial HypertensionDrug: inhaled treprostinilUnited TherapeuticsNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
8NCT01557647
(ClinicalTrials.gov)
June 201214/3/2012Safety and Efficacy of Inhaled Treprostinil in Patients With PAHInhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil.Pulmonary Arterial HypertensionDrug: Inhaled treprostinil;Drug: PlaceboUnited TherapeuticsNULLWithdrawn18 Years75 YearsBoth0Phase 3NULL
9NCT01268553
(ClinicalTrials.gov)
August 201029/12/2010Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin MedicationTransition From Parenteral Prostanoids to Inhaled TreprostinilPulmonary Arterial HypertensionDrug: TreprostinilLos Angeles Biomedical Research InstituteUnited TherapeuticsCompleted18 Years80 YearsAll6Phase 4United States
10NCT01305252
(ClinicalTrials.gov)
July 20102/11/2010A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on TadalafilHypertension, PulmonaryDrug: treprostinil inhalations;Drug: tadalafilStanford UniversityNorthwestern UniversityCompleted18 Years69 YearsAll21Phase 4United States
11NCT00741819
(ClinicalTrials.gov)
September 200823/8/2008Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) SubjectsAn Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension.Pulmonary Arterial HypertensionDrug: Inhaled treprostinilUnited TherapeuticsNULLCompleted18 Years75 YearsAll73Phase 4United States
12EUCTR2004-003236-59-ES
(EUCTR)
14/02/200705/05/2010Investigación clínica doble ciego controlada con placebo sobre la efficacia y la tolerabilidad de Treprostinil sódico inhaldo en pacientes con Hipertensión Pulmonar Graves.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. - Hipertensión Arterial Pulmonar Grave de clase III y IV de la NYHANYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Germany;United Kingdom;Ireland;Spain;Italy
13EUCTR2004-003236-59-IE
(EUCTR)
09/09/200506/07/2005Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. - NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
Lung Rx Inc.NULLNot RecruitingFemale: yes
Male: yes
165Germany;United Kingdom;Spain;Ireland;Italy
14EUCTR2004-003236-59-AT
(EUCTR)
24/08/200520/07/2005Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Spain;Ireland;Austria;Germany;Italy;United Kingdom
15EUCTR2004-003236-59-BE
(EUCTR)
20/08/200515/12/2005Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
16EUCTR2004-003236-59-GB
(EUCTR)
30/06/200513/06/2005 Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
17NCT00147199
(ClinicalTrials.gov)
June 20052/9/2005Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Inhaled treprostinil;Drug: Placebo inhalation solutionUnited TherapeuticsNULLCompleted18 Years75 YearsAll235Phase 3United States;Austria;Belgium;France;Germany;Ireland;Israel;Italy;Spain;United Kingdom
18EUCTR2004-003236-59-IT
(EUCTR)
30/05/200509/11/2009Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial HypertensionDouble Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension NYHA Class III and IV patients with severe Pulmonary Arterial Hypertensio
MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: TRE
INN or Proposed INN: Treprostinil Sodium Solution for Inhalation
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Spain;Ireland;Germany;United Kingdom;Italy
19EUCTR2004-003236-59-DE
(EUCTR)
16/05/2006Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Spain;Ireland;Germany;Italy;United Kingdom