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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 51 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01157156
The ClinicalTrials.gov registry entry for NCT01157156 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which XRP0038 (NV1FGF) is the first listed.
NCT01157156 reports 0 study locations.
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.
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