Trials / Completed
CompletedNCT03691779
Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 6 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | Fixed-dose combination tablet orally once daily in the morning. |
| DRUG | IVA | IVA tablet orally once daily in the evening. |
Timeline
- Start date
- 2018-10-02
- Primary completion
- 2020-08-07
- Completion
- 2020-08-07
- First posted
- 2018-10-02
- Last updated
- 2021-10-22
- Results posted
- 2021-10-22
Locations
21 sites across 5 countries: United States, Australia, Canada, Ireland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03691779. Inclusion in this directory is not an endorsement.