drugset / Trial / NCT05331183
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del
NaSingle-groupOpen-labelTreatment
Summary
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Timeline
- Start
- 2022-11-23
- Primary completion
- 2027-04-06
- Completion
- 2027-04-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivacaftor | Other / unclassified | — | Oral |
| Subject | elexacaftor | Small molecule | — | Oral |
| Subject | tezacaftor | Other / unclassified | — | Oral |