Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation
NCT01707290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2017-05-12
Summary
The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).
Conditions
Interventions
- DRUG
-
Ivacaftor
150 mg tablet, oral use, every 12 hours (q12h)
Sponsors & Collaborators
-
Cystic Fibrosis Foundation
collaborator OTHER -
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Principal Investigators
-
Joseph Pilewski, MD · University of Pittsburgh
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2016-04-30
- Completion
- 2016-04-30
Countries
- United States
- Belgium
- France
- United Kingdom
Study Locations
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