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NCT01685801 · ClinicalTrials.gov registry record · Phase 2
Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function
A Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01685801: Completed Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01685801 is a Phase 2 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01685801, a Phase 2 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator (CFTR) function.
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for each cycle (Cycle 1 and Cycle 2) an
Interventions
- DRUG Ivacaftor
- DRUG Placebo-matched-to-ivacaftor tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01685801 record still lists
NCT01685801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Ivacaftor is the first listed.
NCT01685801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01685801 about?
NCT01685801 is a clinical study titled "Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function". This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator (CFTR) function.
What is the current status of trial NCT01685801?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2012-09. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01685801?
The interventions under investigation include: Ivacaftor (DRUG), Placebo-matched-to-ivacaftor tablet (DRUG).
Who is sponsoring clinical trial NCT01685801?
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 NCT01685801's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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