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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00566657 | Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions | PHASE3 | COMPLETED | 525 | — | — | Nov 1, 2007 | Aug 1, 2012 | May 2, 2016 | 32 | United States, Argentina +30 |
| Arm | Type | Description |
|---|---|---|
| Riferminogene pecaplasmid | EXPERIMENTAL | 4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals |
| Placebo | PLACEBO_COMPARATOR | 4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals |
| Name | Type | Description |
|---|---|---|
| riferminogene pecaplasmid | BIOLOGICAL | Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated |
| Placebo (for riferminogene pecaplasmid) | BIOLOGICAL | Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated |
Inclusion Criteria: * Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene); * With objective evidence of CLI such as ankle systolic pressure \<70 mmHg and/or toe systolic pressure \<50 mmHg or transcutaneous oxygen pressure (T...