NCT01157156

Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease

A Phase I, Multi-Center, Open Label, Safety and Tolerability Study of Single and Repeated Administrations of Escalating Dose(s) of NV1FGF Administered by Intra-Muscular Injection in Patients With Severe Peripheral Artery Occlusive Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Screening period of 30 days before dosing. Patients receive a single administration or repeated (2) administrations (with a 2-week interval) of NV1FGF. Patients are then followed for a period of 6 months

Conditions

• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
DRUG	XRP0038 (NV1FGF)	Pharmaceutical form:solution Route of administration: intramuscular

Timeline

• Start date: 1999-06-01
• Primary completion: 2001-09-01
• Completion: 2001-09-01
• First posted: 2010-07-05
• Last updated: 2010-07-05

Locations

2 sites across 2 countries: United States, Finland