drugset / Trial / NCT03447262
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
NaSingle-groupOpen-labelTreatment
Summary
This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.
Timeline
- Start
- 2018-07-13
- Primary completion
- 2020-09-09
- Completion
- 2020-09-09
Publications
- Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.
- Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAMOCAFTOR | Small molecule | 240 mg | Oral |
| Background | Ivacaftor | Other / unclassified | 150 mg | Oral |
| Background | tezacaftor | Other / unclassified | 100 mg | Oral |