drugset / Trial / NCT04362761
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
NaSingle-groupOpen-labelTreatment
Summary
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
Timeline
- Start
- 2020-05-04
- Primary completion
- 2022-12-21
- Completion
- 2022-12-21
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 | Ivacaftor | Other / unclassified | 150 mg | Oral |
| Subject | elexacaftor | Small molecule | 200 mg | Oral |
| Subject | tezacaftor | Other / unclassified | 100 mg | Oral |