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NCT00865904 · ClinicalTrials.gov registry record · Phase 2
Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation
A Phase 2 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT00865904: Completed Phase 2 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT00865904 is a Phase 2 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 93 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00865904, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
Primary Outcome
AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. Serious adverse event (SAE) (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship t
Conditions Studied
Interventions
- DRUG Placebo
- DRUG VX-809
Study Locations (20)
Ohio
- - Cincinnati
- - Cleveland
- - Columbus
California
- - Palo Alto
- - San Diego
Pennsylvania
- - Philadelphia
- - Pittsburgh
Other
- - Brussels
- - Leuven
Alabama
- - Birmingham
Colorado
- - Aurora
Georgia
- - Atlanta
Illinois
- - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2009-03 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00865904 record still lists
NCT00865904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00865904 names 20 study sites across 15 states, led by Ohio, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00865904 about?
NCT00865904 is a clinical study titled "Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation". The primary objective of the study was to evaluate the safety and tolerability of VX-809 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 NCT00865904?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2009-03. Estimated completion is 2009-12.
What conditions does trial NCT00865904 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT00865904?
The interventions under investigation include: Placebo (DRUG), VX-809 (DRUG).
Who is sponsoring clinical trial NCT00865904?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00865904 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00865904's enrollment target sits among peer trials
93 65th of 169 higher than 105 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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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