Trials / Completed
CompletedNCT03125395
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
A Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for F508del.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUM/IVA | Participants received LUM/IVA every q12h. |
Timeline
- Start date
- 2017-05-12
- Primary completion
- 2019-07-17
- Completion
- 2019-07-17
- First posted
- 2017-04-24
- Last updated
- 2020-08-07
- Results posted
- 2020-08-07
Locations
20 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03125395. Inclusion in this directory is not an endorsement.