Atherosclerosis Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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