Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 1,131 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02565914
The ClinicalTrials.gov registry entry for NCT02565914 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IVA is the first listed.
NCT02565914 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.