NCT00117650

Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 in Patients With Intermittent Claudication

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD). Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.

Detailed description

This Phase 2 gene transfer study will look at whether different doses of Ad2/HIF-1α/VP16 can be tolerated safely by direct injection into the leg muscles where the blood flow is not sufficient to meet the oxygen demands of the leg muscles. The study will also assess whether patients who receive the investigational drug product are able to increase their maximal walking time using a standardized treadmill walking test. The study design is a randomized, double-blind, placebo-controlled, parallel group, multi-center, Phase 2 dose-selection study. Seventy-five patients will be enrolled into each of 4 study drug groups (3 groups of Ad2/HIF-1α/VP16 gene transfer and 1 placebo group) for a total of 300 patients overall. Three different doses of Ad2/HIF-1α/VP16 gene transfer will be studied. The dose range was previously tested in animals and in the Phase 1 human studies. A placebo group is included in the study to compare safety and efficacy of different doses of Ad2/HIF-1α/VP16 with placebo. Each patient will receive a single set of 20 injections (100 μL each) of gene transfer or placebo in one administration to each leg for a total of 40 injections.

Conditions

• Intermittent Claudication
• Peripheral Vascular Disease
• Atherosclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Ad2/HIF-1α/VP16	a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections
BIOLOGICAL	Ad2/HIF-1α/VP16	one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
BIOLOGICAL	Ad2/HIF-1α/VP16	a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
OTHER	Saline (Placebo Control)	a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-09-01
• Completion: 2010-03-01
• First posted: 2005-07-08
• Last updated: 2015-04-03

Locations

47 sites across 3 countries: United States, Germany, United Kingdom