Trials / Completed
CompletedNCT03525444
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 405 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-445/TEZ/IVA | Participants received VX-445/TEZ/IVA orally once daily in the morning. |
| DRUG | IVA | Participants received IVA orally once daily in the evening |
| DRUG | Placebo | Participants received placebo matched VX-445/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening. |
Timeline
- Start date
- 2018-06-15
- Primary completion
- 2019-04-24
- Completion
- 2019-04-24
- First posted
- 2018-05-15
- Last updated
- 2020-05-19
- Results posted
- 2020-05-19
Locations
115 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Italy, Netherlands, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03525444. Inclusion in this directory is not an endorsement.