Trials / Completed
CompletedNCT02390219
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
A Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR Mutation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lumacaftor | |
| DRUG | Ivacaftor |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2015-03-17
- Last updated
- 2017-12-06
- Results posted
- 2017-11-01
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02390219. Inclusion in this directory is not an endorsement.