A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation
NCT03068312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2020-02-26
Summary
This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.
Conditions
Interventions
- DRUG
-
Ivacaftor
IVA 150 mg tablet.
- DRUG
-
Placebo matched to IVA tablet.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-18
- Primary Completion
- 2018-12-18
- Completion
- 2018-12-18
- FDA Drug
- Yes
Countries
- Israel
Study Locations
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