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NCT00953706 · ClinicalTrials.gov registry record · Phase 2
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation
A Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Terminated
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT00953706: Clinical Trial Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT00953706 is a Phase 2 study that was terminated before completion, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00953706, a Phase 2 study, was terminated before completion, sponsored by Vertex Pharmaceuticals Incorporated.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.
Primary Outcome
Spirometry (as measured by ppFEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Knudson method.
Interventions
- DRUG Placebo
- DRUG Ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
Why NCT00953706 stopped before completion
NCT00953706 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00953706 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00953706 about?
NCT00953706 is a clinical study titled "Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation". The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent and selective CFTR potentiator of...
What is the current status of trial NCT00953706?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2009-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00953706?
The interventions under investigation include: Placebo (DRUG), Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT00953706?
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 NCT00953706's enrollment target sits among peer trials
140 512th of 2000 higher than 1,476 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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