drugset / Trial / NCT04545515
A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes
NaSingle-groupOpen-labelTreatment
Summary
The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in participants with CF who are 6 years of age and older with F/MF genotypes.
Timeline
- Start
- 2021-01-11
- Primary completion
- 2023-03-24
- Completion
- 2023-03-24
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 | ELX/TEZ/IVA | Unknown | 100 mg | Oral |
| Subject | ELX/TEZ/IVA | Unknown | 200 mg | Oral |
| Subject | Ivacaftor | Other / unclassified | 75 mg | Oral |
| Subject | Ivacaftor | Other / unclassified | 150 mg | Oral |
| Subject | tezacaftor | Other / unclassified | 50 mg | Oral |
| Subject | tezacaftor | Other / unclassified | 100 mg | Oral |