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| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00117650 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intermittent Claudication Peripheral Vascular Disease Atherosclerosis |
Biological: Ad2/HIF-1α/VP16 Other: Saline (Placebo Control) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 289 |
| Study Start Date: | February 2005 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Low Dose
2 x 10^9 vp (viral particles)
|
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 Name: HIF-1alpha
|
|
Active Comparator: Middle Dose
2 x 10^10 vp
|
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.
Other Name: HIF-1alpha
|
|
Active Comparator: High Dose
2 x 10^11 vp
|
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 Name: HIF-1alpha
|
|
Placebo Comparator: Placebo
(PBS + 10% sucrose + 0.02% polysorbate 80)
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 47 Study Locations| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00117650 History of Changes |
| Other Study ID Numbers: | PADHIF00704, 2004-002508-13 |
| Study First Received: | June 30, 2005 |
| Last Updated: | October 2, 2010 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Paul-Ehrlich-Institut |
|
leg pain gene transfer angiogenesis |
Phase 2 Genzyme peripheral arterial disease |
|
Atherosclerosis Intermittent Claudication Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases |
Signs and Symptoms Etoposide Etoposide phosphate Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |