Trials / Completed
CompletedNCT04599465
A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)
A Phase 3b Open-label Study to Assess the Effect of Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study was evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose metabolism.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | Fixed dose combination (FDC) tablets for oral administration. |
| DRUG | IVA | Tablets for oral administration. |
Timeline
- Start date
- 2021-01-15
- Primary completion
- 2022-07-14
- Completion
- 2022-07-14
- First posted
- 2020-10-22
- Last updated
- 2023-08-03
- Results posted
- 2023-08-03
Locations
41 sites across 7 countries: Australia, Belgium, Czechia, France, Italy, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04599465. Inclusion in this directory is not an endorsement.