Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117650
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2005-06-30
Brief Title:
Safety and Efficacy Study of Ad2Hypoxia Inducible Factor HIF-1αVP16 Gene Transfer in Patients With Intermittent Claudication
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Parallel-group Multicenter Dose-Selection Study of Ad2Hypoxia Inducible Factor HIF-1αVP16 in Patients With Intermittent Claudication
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WALK
Brief Summary:
The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent Ad2HIF-1αVP16 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 patients walking ability is severely limited causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs
Specifically this study will enroll patients with severe intermittent claudication IC which is the stage of PAD in which a patients 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 Ad2HIF-1αVP16 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 Ad2HIF-1αVP16 gene transfer and 1 placebo group for a total of 300 patients overall Three different doses of Ad2HIF-1αVP16 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 Ad2HIF-1αVP16 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
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 Ad2HIF-1αVP16 gene transfer and 1 placebo group for a total of 300 patients overall Three different doses of Ad2HIF-1αVP16 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 Ad2HIF-1αVP16 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-002508-13 | EUDRACT_NUMBER | None | None |