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

NCT00117650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2015-04-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2008-09-30
Completion
2010-03-31

Countries

  • United States
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00117650 on ClinicalTrials.gov