Trials / Completed
CompletedNCT04969224
A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)
A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | Fixed dose combination (FDC) tablet for oral administration. |
| DRUG | IVA | Tablet for oral administration. |
Timeline
- Start date
- 2021-10-12
- Primary completion
- 2022-07-26
- Completion
- 2022-07-26
- First posted
- 2021-07-20
- Last updated
- 2025-09-24
- Results posted
- 2023-10-03
Locations
19 sites across 4 countries: Australia, Belgium, Canada, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04969224. Inclusion in this directory is not an endorsement.