Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

May 27, 2016

Study Completion Date

May 27, 2016

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-661

Tablet, oral use

DRUG

Ivacaftor

Film coated tablet, oral use

DRUG

Placebo matched to VX-661

Tablet, oral use

DRUG

Placebo matched to Ivacaftor

Film coated tablet, oral use

Trial Locations (23)

Unknown

Birmingham

Palo Alto

Stanford

Altamonte Springs

Miami

Orlando

Tampa

Boise

Chicago

Boston

New Brunswick

New York

Durham

Cincinnati

Oklahoma City

Pittsburgh

Charleston

Memphis

Houston

Burlington

Colchester

Seattle

Milwaukee

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT02070744 - Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion | Biotech Hunter | Biotech Hunter