Trials / Completed
CompletedNCT04105972
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 176 (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 homozygous for F508del.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | FDC tablet for oral administration. |
| DRUG | TEZ/IVA | Fixed-dose combination (FDC) tablet for oral administration. |
| DRUG | IVA | Mono tablet for oral administration. |
Timeline
- Start date
- 2019-10-03
- Primary completion
- 2020-07-24
- Completion
- 2020-07-24
- First posted
- 2019-09-26
- Last updated
- 2021-08-18
- Results posted
- 2021-08-18
Locations
35 sites across 4 countries: Australia, Belgium, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04105972. Inclusion in this directory is not an endorsement.