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Generated: February 15, 2019

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CLINICAL TRIALS PROFILE FOR IVACAFTOR; LUMACAFTOR

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Clinical Trials for Ivacaftor; Lumacaftor

Trial ID Title Status Sponsor Phase Summary
NCT01225211 Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 2 The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.
NCT01768663 A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects Completed Vertex Pharmaceuticals Incorporated Phase 1 The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.
NCT01807923 A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
NCT01807949 A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
NCT01888393 Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects Completed Vertex Pharmaceuticals Incorporated Phase 1 This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
NCT01897233 Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
NCT01899105 A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor Completed Vertex Pharmaceuticals Incorporated Phase 1 This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ivacaftor; Lumacaftor

Condition Name

Condition Name for Ivacaftor; Lumacaftor
Intervention Trials
Cystic Fibrosis 26
Diabetes 2
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation 2
Hepatic Impairment 1
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Condition MeSH

Condition MeSH for Ivacaftor; Lumacaftor
Intervention Trials
Cystic Fibrosis 29
Fibrosis 22
Lung Diseases 2
Disease Progression 1
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Clinical Trial Locations for Ivacaftor; Lumacaftor

Trials by Country

Trials by Country for Ivacaftor; Lumacaftor
Location Trials
United States 284
Canada 23
France 21
United Kingdom 19
Germany 17
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Trials by US State

Trials by US State for Ivacaftor; Lumacaftor
Location Trials
Missouri 13
California 12
Massachusetts 12
Pennsylvania 11
Ohio 11
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Clinical Trial Progress for Ivacaftor; Lumacaftor

Clinical Trial Phase

Clinical Trial Phase for Ivacaftor; Lumacaftor
Clinical Trial Phase Trials
Phase 4 2
Phase 3 11
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Ivacaftor; Lumacaftor
Clinical Trial Phase Trials
Completed 13
Recruiting 8
Not yet recruiting 5
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Clinical Trial Sponsors for Ivacaftor; Lumacaftor

Sponsor Name

Sponsor Name for Ivacaftor; Lumacaftor
Sponsor Trials
Vertex Pharmaceuticals Incorporated 20
Nivalis Therapeutics, Inc. 2
Massachusetts General Hospital 2
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Sponsor Type

Sponsor Type for Ivacaftor; Lumacaftor
Sponsor Trials
Industry 23
Other 11
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Queensland Health
UBS
Julphar
Medtronic
Chinese Patent Office
Fuji
Johnson and Johnson

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