drugset / Trial / NCT03277196
A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Participants With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an approved Ivacaftor-Responsive mutation.
Timeline
- Start
- 2017-08-16
- Primary completion
- 2023-10-02
- Completion
- 2023-10-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivacaftor | Other / unclassified | 25 mg | Oral |
| Subject | Ivacaftor | Other / unclassified | 50 mg | Oral |
| Subject | Ivacaftor | Other / unclassified | 75 mg | Oral |