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Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation

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

Summary

The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF.

Secondary objectives :

- To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF

- To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site)

- To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site)

- To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma

- To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site

- To collect data from plasma NV1FGF pharmacokinetics

- To evaluate healing of the amputation site

Description

Screening of 1 to 4 weeks before study drug administration; Single study drug administration 3 to 8 days before planned amputation; 6 months of follow up

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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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