CLINICAL TRIALS PROFILE FOR IVACAFTOR; LUMACAFTOR

All Clinical Trials for IVACAFTOR; LUMACAFTOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	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	2010-10-01	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	2013-01-01	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	2013-05-01	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	2013-04-01	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	2013-06-01	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.

Clinical Trial Conditions for IVACAFTOR; LUMACAFTOR

Condition Name

Condition Name for IVACAFTOR; LUMACAFTOR
Intervention	Trials
Cystic Fibrosis	30
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	2
Diabetes	2
Healthy	1

Condition MeSH

Condition MeSH for IVACAFTOR; LUMACAFTOR
Intervention	Trials
Cystic Fibrosis	33
Fibrosis	27
Lung Diseases	2
Hyperglycemia	1

Clinical Trial Locations for IVACAFTOR; LUMACAFTOR

Trials by Country

Trials by Country for IVACAFTOR; LUMACAFTOR
Location	Trials
United States	371
Canada	31
France	23
United Kingdom	19
Germany	19

Trials by US State

Trials by US State for IVACAFTOR; LUMACAFTOR
Location	Trials
Missouri	16
Colorado	16
Ohio	15
Massachusetts	15
California	15

Clinical Trial Progress for IVACAFTOR; LUMACAFTOR

Clinical Trial Phase

Clinical Trial Phase for IVACAFTOR; LUMACAFTOR
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	12
Phase 2	5

Clinical Trial Status

Clinical Trial Status for IVACAFTOR; LUMACAFTOR
Clinical Trial Phase	Trials
Completed	22
Recruiting	5
Terminated	3

Clinical Trial Sponsors for IVACAFTOR; LUMACAFTOR

Sponsor Name

Sponsor Name for IVACAFTOR; LUMACAFTOR
Sponsor	Trials
Vertex Pharmaceuticals Incorporated	21
Massachusetts General Hospital	2
Children's Hospital Medical Center, Cincinnati	2

Sponsor Type

Sponsor Type for IVACAFTOR; LUMACAFTOR
Sponsor	Trials
Industry	25
Other	15
NIH	1