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

Phase 1

Completed

• Conditions: Peripheral Arterial Occlusive Disease

• Registration Number: NCT01157156
• Lead Sponsor: Sanofi

Brief 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

Study Timeline

• Study Start: 1999-06
• Primary Completion: 2001-09
• Study Completion: 2001-09
• Status Verified: 2010-07
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Last Update Submitted: 2010-07-02
• Study First Posted: 2010-07-05
• Last Update Posted: 2010-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...)	12 weeks

Secondary Outcome Measures

Name	Time	Method
ulcers healing assessment (length, width, type, depth)	12 weeks
pain assessment (self-administered visual analog scale)	12 weeks
hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography	12 weeks