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NCT00566657 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 525
- Enrollment target
NCT00566657: Completed Phase 3 study, sponsored by Sanofi.
NCT00566657 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 525 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00566657, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 525 participants
- Enrollment target
Study Summary
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions. Secondary objectives are to evaluate: * The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation; * The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death; * The safety of riferminogene pecaplasmid in the study population.
Interventions
- BIOLOGICAL riferminogene pecaplasmid
- BIOLOGICAL Placebo (for riferminogene pecaplasmid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT00566657 record still lists
NCT00566657 is an interventional study that assigns participants to a tested intervention. The registered 525 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which riferminogene pecaplasmid is the first listed.
NCT00566657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00566657 about?
NCT00566657 is a clinical study titled "Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions". Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions. Seco...
What is the current status of trial NCT00566657?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 525 participants. The study started on 2007-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00566657?
The interventions under investigation include: riferminogene pecaplasmid (BIOLOGICAL), Placebo (for riferminogene pecaplasmid) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00566657?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00566657's enrollment target sits among peer trials
525 715th of 2000 higher than 1,285 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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