Trials / Completed
CompletedNCT03559062
A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis
A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 6 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TEZ/IVA | Participants weighing \<40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet. |
| DRUG | IVA | Participants weighing \<40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet. |
| DRUG | Placebo | Placebo matched to TEZ/IVA FDC |
| DRUG | Placebo | Placebo matched to IVA |
Timeline
- Start date
- 2018-05-17
- Primary completion
- 2018-12-21
- Completion
- 2018-12-21
- First posted
- 2018-06-15
- Last updated
- 2020-02-11
- Results posted
- 2020-02-11
Locations
27 sites across 9 countries: Australia, Belgium, Denmark, France, Germany, Ireland, Poland, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03559062. Inclusion in this directory is not an endorsement.