Trials / Completed
CompletedNCT04058353
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
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 Gating or Residual Function Mutation (F/G and F/RF Genotypes)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 271 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, 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 gating or residual function mutation (F/G and F/RF genotypes).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | FDC tablet for oral administration. |
| DRUG | IVA | Mono-tablet for oral administration. |
| DRUG | TEZ/IVA | Fixed-dose combination (FDC) tablet for oral administration. |
Timeline
- Start date
- 2019-08-28
- Primary completion
- 2020-06-12
- Completion
- 2020-06-12
- First posted
- 2019-08-15
- Last updated
- 2021-07-02
- Results posted
- 2021-07-02
Locations
93 sites across 13 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04058353. Inclusion in this directory is not an endorsement.