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NCT01157156 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT01157156: Completed Phase 1 study, sponsored by Sanofi.
NCT01157156 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01157156, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6). Secondary objectives are: * To determine the biological activity of NV1FGF on collateral artery development. * To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.
Interventions
- DRUG XRP0038 (NV1FGF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 1999-06 |
| Est. Completion | 2001-09 |
| Phase | Phase 1 |
What the finished NCT01157156 record still lists
NCT01157156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which XRP0038 (NV1FGF) is the first listed.
NCT01157156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01157156 about?
NCT01157156 is a clinical study titled "Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease". The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6). Seco...
What is the current status of trial NCT01157156?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 1999-06. Estimated completion is 2001-09.
What interventions are being tested in trial NCT01157156?
The interventions under investigation include: XRP0038 (NV1FGF) (DRUG).
Who is sponsoring clinical trial NCT01157156?
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 NCT01157156's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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