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NCT02508207 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
A Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT02508207: Completed Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02508207 is a Phase 2 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02508207, a Phase 2 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
Primary Outcome
MCC was assessed using an imaging technique that enables the tracking of mucus within the airways. MCC was expressed as the percentage of whole-lung clearance through 60 minutes at Baseline and Day 28.
Interventions
- DRUG Ivacaftor
- DRUG Tezacaftor/Ivacaftor
- DRUG Tezacaftor/Ivacaftor matching placebo
- DRUG Ivacaftor matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-02 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
What the finished NCT02508207 record still lists
NCT02508207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 4 interventions - of which Ivacaftor is the first listed.
NCT02508207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02508207 about?
NCT02508207 is a clinical study titled "A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation". To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
What is the current status of trial NCT02508207?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2016-02. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02508207?
The interventions under investigation include: Ivacaftor (DRUG), Tezacaftor/Ivacaftor (DRUG), Tezacaftor/Ivacaftor matching placebo (DRUG), Ivacaftor matching placebo (DRUG).
Who is sponsoring clinical trial NCT02508207?
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 NCT02508207's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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