299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170

  
81 trials found
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PhaseCountries
1NCT04235140
(ClinicalTrials.gov)
February 24, 202015/1/2020Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationA Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 MonthsN/AAll52Phase 3United States;Canada
2EUCTR2019-001314-41-NL
(EUCTR)
06/05/201906/05/2019This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor.Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Orkambi: contains lumacaftor and ivacaftor
Product Name: Orkambi
Trade Name: Symkevi
Product Name: Symkevi
Trade Name: Kalydeco
Product Name: Kalydeco
NULLNot RecruitingFemale: yes
Male: yes
100Phase 4Netherlands
3NCT03956589
(ClinicalTrials.gov)
October 1, 20182/5/2019Functional Respiratory Imaging and Orkambi in CFFunctional Respiratory Imaging (FRI) to Assess the Short-term Effect of the Product ORKAMBI (Lumacaftor/ Ivacaftor) on Lung Function in ORKAMBInaive Patients With Cystic Fibrosis Homozygous for Phe508delCystic FibrosisDrug: OrkambiUniversity Hospital, AntwerpNULLTerminated12 YearsN/AAll12Phase 4Belgium
4NCT03601637
(ClinicalTrials.gov)
August 23, 201818/7/2018Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508delA Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508delCystic FibrosisDrug: LUM;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted12 Months23 MonthsAll60Phase 3United States;Canada
5NCT03625466
(ClinicalTrials.gov)
August 10, 20187/8/2018A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delAn Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delCystic FibrosisDrug: LUM;Drug: IVA;Drug: Matched PlacebosVertex Pharmaceuticals IncorporatedNULLActive, not recruiting2 Years5 YearsAll51Phase 2Germany
6NCT04732910
(ClinicalTrials.gov)
July 1, 201825/1/2021Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulatorsCFTR Biomarker Studie Bei Patient*Innen Mit Mukoviszidose Und CFTR-ModulatortherapieCystic FibrosisDrug: Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-IvacaftorCharite University, Berlin, GermanyHannover Medical School;Heidelberg University;University of GiessenRecruiting6 MonthsN/AAll90Germany
7NCT03565692
(ClinicalTrials.gov)
July 1, 201831/5/2018Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-IvacaftorLum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-IvacaftorCystic FibrosisBiological: the lung mycobiota and microbiota profile;Biological: the gut mycobiota and microbiota profileUniversity Hospital, BordeauxSociete Francaise de la MucoviscidoseRecruiting2 YearsN/AAll250France
8EUCTR2017-003761-99-DE
(EUCTR)
27/06/201819/02/2018A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delAn Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Orkambi 100 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Germany
9EUCTR2018-001573-24-BE
(EUCTR)
11/06/201808/05/2018Evaluation of the short-term effect of ORKAMBI on lung function in patients with cystic fibrosis who have two copies of the F508del mutation using functional respiratory imagingFunctional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaftor/ ivacaftor) on lung function in ORKAMBI-naive patients with Cystic Fibrosis Homozygous for Phe508del. Cystic Fibrosis Homozygous (homozygous for the F508del mutation)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Orkambi
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Antwerp University HospitalNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Belgium
10NCT02653027
(ClinicalTrials.gov)
January 1, 20187/1/2016Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508delA Study of the Effect of Combination Lumacaftor and Ivacaftor on Glucose Tolerance in Persons With Cystic Fibrosis Who Are Homozygous for the Phe508del Cystic Fibrosis Transmembrane Conductance Regulator Mutation.Diabetes;Cystic FibrosisDrug: Lumacaftor-ivacaftor;Other: OGTTMassachusetts General HospitalNULLWithdrawn18 Years65 YearsAll0N/ANULL
11NCT03150719
(ClinicalTrials.gov)
May 24, 20173/5/2017A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR MutationCystic FibrosisDrug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll98Phase 3United States;France;Germany
12NCT03125395
(ClinicalTrials.gov)
May 12, 201719/4/2017A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLCompleted2 YearsN/AAll57Phase 3United States;Canada
13EUCTR2016-004996-33-ES
(EUCTR)
03/05/201710/03/2017A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del-CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation
MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi
Product Name: Orkambi
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Vertex Pharmaceuticals IncoporatedNULLNot RecruitingFemale: yes
Male: yes
75Phase 4United States;Canada;Spain;Australia;United Kingdom
14NCT03061331
(ClinicalTrials.gov)
January 31, 20179/2/2017Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR MutationCystic FibrosisDrug: LUM/IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll20Phase 2Netherlands
15EUCTR2015-004841-13-CZ
(EUCTR)
04/01/201710/08/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Ivacaftor
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
16NCT04623879
(ClinicalTrials.gov)
December 29, 201612/10/2020Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftor on F508del Homozygous Cystic Fibrosis Patients.Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftor on F508del Homozygous Cystic Fibrosis Patients.Cystic FibrosisDrug: Lumacaftor, Ivacaftor Drug CombinationCarmel Medical CenterNULLCompleted18 Years99 YearsAll13NULL
17EUCTR2016-001585-29-NL
(EUCTR)
21/12/201618/07/2016Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi 200 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Netherlands
18NCT02875366
(ClinicalTrials.gov)
September 201615/8/2016A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR MutationA Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll70Phase 4Australia;United Kingdom
19EUCTR2015-004841-13-IE
(EUCTR)
08/08/201607/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic Saline
INN or Proposed INN: 4.2% NaCl/Inhalation solution
Vertex Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
20NCT02858843
(ClinicalTrials.gov)
August 1, 20165/7/2016The Effect of Combination Lumacaftor and Ivacaftor on Markers of HyperglycemiaA Study of the Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia in Persons With Cystic FibrosisCystic Fibrosis;DiabetesDrug: lumacaftor-ivacaftorMassachusetts General HospitalNULLTerminated18 Years65 YearsAll1N/ANULL
21EUCTR2015-004841-13-GB
(EUCTR)
20/07/201609/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/Inhalation solution
Vertex Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Ireland;United Kingdom
22EUCTR2016-000066-34-GB
(EUCTR)
24/06/201625/07/2017A Study of the Effects of Lumacaftor/Ivacaftor on Exercise Tolerance in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation. Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesAustralia;United Kingdom
23NCT02807415
(ClinicalTrials.gov)
June 1, 201616/6/2016ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With IvacaftorIntestinal Current Measurements (ICM) to Evaluate the Activation of Mutant CFTR in Subjects With Cystic Fibrosis Aged 12 Years and Older, Homozygous for the p.Phe508del-CFTR Mutation, Treated With Lumacaftor in Combination With IvacaftorCystic FibrosisDrug: Lumacaftor plus IvacaftorHannover Medical SchoolHeidelberg University;University of GiessenCompleted6 YearsN/AAll104Germany
24NCT02823470
(ClinicalTrials.gov)
June 20161/7/2016A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del CFTR MutationCystic FibrosisDrug: LUM/IVA;Device: activated smart device;Device: de-activated smart deviceVertex Pharmaceuticals IncorporatedNULLTerminated16 YearsN/AAll24Phase 4United States;Canada
25EUCTR2015-001644-11-DE
(EUCTR)
25/05/201631/03/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
26NCT02797132
(ClinicalTrials.gov)
May 201625/5/2016Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delA Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLCompleted2 Years5 YearsAll62Phase 3United States;Canada
27EUCTR2015-001644-11-BE
(EUCTR)
06/04/201608/01/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
28EUCTR2015-001644-11-FR
(EUCTR)
16/03/201620/04/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
29EUCTR2015-001644-11-DK
(EUCTR)
15/03/201608/02/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
30NCT03512119
(ClinicalTrials.gov)
February 11, 201615/1/2018Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorObservational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorCystic Fibrosis Homozygous for Phe 508 Del CFTR;Glucose Intolerance or Newly Diagnosis DiabetesDrug: Lumacaftor-Ivacaftor treatmentUniversity Hospital, Strasbourg, FranceNULLCompleted12 YearsN/AAll55France
31EUCTR2015-001644-11-GB
(EUCTR)
22/01/201610/11/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
32NCT02589236
(ClinicalTrials.gov)
November 201526/10/2015Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.Medidata SolutionsCompleted18 YearsN/AAll138Phase 2United States
33EUCTR2015-000543-16-DE
(EUCTR)
14/10/201518/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
34EUCTR2015-000543-16-BE
(EUCTR)
24/09/201508/06/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
35EUCTR2015-000543-16-DK
(EUCTR)
23/09/201522/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
36EUCTR2015-000543-16-SE
(EUCTR)
19/08/201520/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
37NCT02544451
(ClinicalTrials.gov)
August 20151/9/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With IvacaftorA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLCompleted6 YearsN/AAll246Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom
38NCT02514473
(ClinicalTrials.gov)
July 201523/7/2015A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR MutationA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: VX-809;Drug: Placebo;Drug: VX-770Vertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll206Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom
39EUCTR2015-000543-16-GB
(EUCTR)
19/06/201515/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
40NCT02390219
(ClinicalTrials.gov)
March 201511/3/2015Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung DiseaseA Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR MutationCystic Fibrosis;Advanced Lung DiseaseDrug: Lumacaftor;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll46Phase 3United States
41EUCTR2013-000604-41-DE
(EUCTR)
10/03/201420/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
42EUCTR2013-000604-41-NL
(EUCTR)
14/02/201426/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
43EUCTR2013-000604-41-IT
(EUCTR)
21/01/201414/08/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
44EUCTR2010-020413-90-IE
(EUCTR)
08/01/201413/12/2013Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Belgium;Ireland;Australia;Germany;United Kingdom
45EUCTR2010-020413-90-GB
(EUCTR)
06/01/201410/12/2013Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot 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): noUnited States;Belgium;Ireland;Australia;Germany;United Kingdom
46EUCTR2013-000604-41-CZ
(EUCTR)
18/12/201313/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
47EUCTR2013-000604-41-SE
(EUCTR)
10/12/201313/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
48EUCTR2013-000604-41-IE
(EUCTR)
09/12/201310/10/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
49EUCTR2013-000604-41-BE
(EUCTR)
04/12/201317/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
50EUCTR2013-000604-41-ES
(EUCTR)
03/12/201308/10/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
51EUCTR2013-000604-41-DK
(EUCTR)
19/11/201319/11/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
52EUCTR2013-000604-41-AT
(EUCTR)
23/10/201316/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
53EUCTR2013-000604-41-GB
(EUCTR)
10/10/201317/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
54NCT01931839
(ClinicalTrials.gov)
October 201326/8/2013A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic FibrosisA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationDrug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll1164Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
55EUCTR2012-003990-24-AT
(EUCTR)
26/08/201303/04/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Australia;Austria;Germany;United Kingdom
56EUCTR2012-003989-40-NL
(EUCTR)
21/08/201317/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
57EUCTR2012-003990-24-ES
(EUCTR)
09/08/201316/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3France;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
58NCT01899105
(ClinicalTrials.gov)
July 201310/7/2013A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With IvacaftorA Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult SubjectsCystic FibrosisDrug: lumacaftor;Drug: ivacaftorVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsBoth28Phase 1United States
59NCT01897233
(ClinicalTrials.gov)
July 20138/7/2013Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: Lumacaftor;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll62Phase 3United States;Canada
60EUCTR2012-003990-24-DK
(EUCTR)
27/06/201317/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Austria;Australia;Denmark;Germany;United Kingdom
61EUCTR2012-003989-40-CZ
(EUCTR)
26/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
62EUCTR2012-003990-24-BE
(EUCTR)
25/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
63EUCTR2012-003990-24-DE
(EUCTR)
20/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
64EUCTR2012-003990-24-GB
(EUCTR)
10/06/201313/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
65EUCTR2012-003989-40-GB
(EUCTR)
10/06/201313/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
66EUCTR2012-003989-40-IE
(EUCTR)
07/06/201311/04/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
67NCT01910415
(ClinicalTrials.gov)
June 201319/7/2013Phase 1, QT/QTC Interval Study in Healthy SubjectsA Phase 1, Randomized, Placebo and Active Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of Lumacaftor in Combination With Ivacaftor on the QT/QTc Interval in Healthy SubjectsCystic FibrosisDrug: Lumacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor;Drug: Ivacaftor Placebo;Drug: moxifloxacin hydrochlorideVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsBoth200Phase 1Netherlands
68EUCTR2012-003989-40-IT
(EUCTR)
22/05/201321/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
69EUCTR2012-003989-40-DE
(EUCTR)
17/05/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
70EUCTR2012-003989-40-SE
(EUCTR)
07/05/201318/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
71NCT01807923
(ClinicalTrials.gov)
May 20134/3/2013A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous for the F508del CFTR MutationDrug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll559Phase 3United States;Australia;Canada;Czech Republic;France;Germany;Ireland;Italy;Netherlands;Sweden;United Kingdom
72NCT01807949
(ClinicalTrials.gov)
April 20134/3/2013A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous for the F508del CFTR MutationDrug: Placebo;Drug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 Years65 YearsAll563Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Spain;United Kingdom
73NCT01768663
(ClinicalTrials.gov)
January 201311/1/2013A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult SubjectsA Phase 1, Open-Label Study to Examine the Effect of Ciprofloxacin, Itraconazole, and Rifampin on the Pharmacokinetics of Lumacaftor in Combination With Ivacaftor in Healthy Adult SubjectsCystic FibrosisDrug: Lumacaftor;Drug: Ivacaftor;Drug: Ciprofloxacin;Drug: Itraconazole;Drug: RifampinVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsBoth80Phase 1United States
74EUCTR2010-020413-90-BE
(EUCTR)
08/02/201115/10/2010Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
293Phase 2United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand
75EUCTR2010-020413-90-DE
(EUCTR)
06/01/201115/10/2010Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
293Phase 2New Zealand;United Kingdom;Germany;Australia;Belgium;United States
76NCT01225211
(ClinicalTrials.gov)
October 201015/10/2010Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: Lumacaftor;Drug: Ivacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll312Phase 2United States;Australia;Belgium;France;Germany;New Zealand;United Kingdom;Ireland
77EUCTR2015-004841-13-FR
(EUCTR)
23/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Ivacaftor
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Czech Republic;Ireland;United Kingdom
78EUCTR2015-000543-16-FR
(EUCTR)
07/07/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
79EUCTR2015-001644-11-SE
(EUCTR)
05/11/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
256Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
80EUCTR2017-001309-34-Outside-EU/EEA
(EUCTR)
29/03/2017Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung DiseaseA Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: lumacaftor/ivacaftor
Product Name: lumacaftor/ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
46Phase 3United States
81EUCTR2017-001078-41-Outside-EU/EEA
(EUCTR)
27/03/2017A study in people with cystic fibrosis (a rare pulmonary disease) to assess the pharmacokinetics and safety of a combination of two experimental drugsA Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: lumacaftor/ivacaftor
Product Name: lumacaftor/ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
58Phase 3United States;Canada