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NCT02565914 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,131
- Enrollment target
NCT02565914: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02565914 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 1,131 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02565914, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,131 participants
- Enrollment target
Study Summary
This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744), VX14-661-106 (Study 106, NCT02347657), VX14-661-107 (Study 107, NCT02516410), VX14-661-108 (Study 108, NCT02392234), VX14-661-109 (Study 109, NCT02412111), VX14-661-111 (Study 111, NCT02508207), VX15-661-112 (NCT02730208), and VX16-661-114 (NCT03150719). The study is designed to evaluate the safety and efficacy of long-term treatment of VX-661 in combination with ivacaftor.
Interventions
- DRUG IVA
- DRUG TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,131 participants |
| Start Date | 2015-08 |
| Est. Completion | 2022-12-05 |
| Phase | Phase 3 |
What the finished NCT02565914 record still lists
NCT02565914 is an interventional study that assigns participants to a tested intervention. Its 1,131 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which IVA is the first listed.
NCT02565914 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02565914 about?
NCT02565914 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation". This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744), VX14-661-106 (Study 106, NCT02347657), VX14-661-107 (Study 107, NCT02516410), ...
What is the current status of trial NCT02565914?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,131 participants. The study started on 2015-08. Estimated completion is 2022-12-05.
What interventions are being tested in trial NCT02565914?
The interventions under investigation include: IVA (DRUG), TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT02565914?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02565914's enrollment target sits among peer trials
1,131 245th of 2000 higher than 1,755 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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