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

2014-08-27 03:12:24 | BioPortfolio

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.

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Peripheral Arterial Occlusive Disease

Intervention

XRP0038 (NV1FGF)

Location

Minneapolis
Minnesota
United States

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:24-0400

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