Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00117650 | Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication | PHASE2 | COMPLETED | 289 | — | — | Feb 1, 2005 | Mar 1, 2010 | Apr 3, 2015 | 47 | United States, Germany +1 |
| Arm | Type | Description |
|---|---|---|
| Low Dose | ACTIVE_COMPARATOR | 2 x 10\^9 vp (viral particles) |
| Middle Dose | ACTIVE_COMPARATOR | 2 x 10\^10 vp |
| High Dose | ACTIVE_COMPARATOR | 2 x 10\^11 vp |
| Placebo | PLACEBO_COMPARATOR | (PBS + 10% sucrose + 0.02% polysorbate 80) |
| Name | Type | Description |
|---|---|---|
| Ad2/HIF-1α/VP16 | BIOLOGICAL | a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections |
| Saline (Placebo Control) | OTHER | a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections. |
Inclusion Criteria: * Males and females 40 to 80 years of age, inclusive. * Clinical diagnosis of PAD, secondary to atherosclerosis, in both lower limbs, confirmed by objective evidence: An ankle-brachial index (ABI) of ≤ 0.90 at rest in at least 1 lower limb (Note: The index limb must be ≤ 0.90 at...