Trials / Completed
CompletedNCT02730208
A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tezacaftor/Ivacaftor | TEZ 100 mg/IVA 150 mg fixed-dose combination tablet. |
| DRUG | Ivacaftor | IVA 150 mg tablet. |
| DRUG | Placebo | Placebo matched to TEZ/IVA fixed-dose combination tablet. |
| DRUG | Placebo | Placebo matched to IVA tablet. |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-07-01
- Completion
- 2018-07-01
- First posted
- 2016-04-06
- Last updated
- 2019-10-23
- Results posted
- 2019-08-21
Locations
9 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT02730208. Inclusion in this directory is not an endorsement.