drugset / Trial / NCT02730208
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
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2016-09
- Primary completion
- 2018-07
- Completion
- 2018-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivacaftor | Other / unclassified | 150 mg | Oral |
| Subject | tezacaftor | Other / unclassified | 100 mg | — |