drugset / Trial / NCT05274269
Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluated the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.
Timeline
- Start
- 2022-05-09
- Primary completion
- 2023-07-05
- Completion
- 2023-07-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivacaftor | Other / unclassified | 75 mg | Oral |
| Subject | Ivacaftor | Other / unclassified | 150 mg | Oral |
| Subject | elexacaftor | Small molecule | 100 mg | Oral |
| Subject | elexacaftor | Small molecule | 200 mg | Oral |
| Subject | tezacaftor | Other / unclassified | 50 mg | Oral |
| Subject | tezacaftor | Other / unclassified | 100 mg | Oral |