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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01157871 | Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication | PHASE2 | COMPLETED | 36 | — | — | Jun 1, 2004 | Aug 1, 2005 | Jul 7, 2010 | 4 | United States, Belgium +2 |
| NCT01157143 | Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation | PHASE1 | COMPLETED | 6 | — | — | Jan 1, 2002 | Oct 1, 2003 | Jul 5, 2010 | 2 | United States, Switzerland |
| NCT01157156 | Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease | PHASE1 | COMPLETED | 51 | — | — | Jun 1, 1999 | Sep 1, 2001 | Jul 5, 2010 | 2 | United States, Finland |
| Arm | Type | Description |
|---|---|---|
| placebo | EXPERIMENTAL | 4 administrations at 2-week interval of placebo solution |
| NV1FGF 16 mg | EXPERIMENTAL | 4 administrations at 2-week interval of 4mg at each administration |
| NV1FGF 32 mg | EXPERIMENTAL | 4 administrations at 2-week interval of 8mg at each administration |
| NV1FGF 500 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 500 μg administered in one single administration 3 to 8 days before major amputation |
| NV1FGF 2000 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 2000 μg administered in one single administration 3 to 8 days before major amputation |
| NV1FGF 4000 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 4000 μg administered in one single administration 3 to 8 days before major amputation |
| Name | Type | Description |
|---|---|---|
| XRP0038 (NV1FGF) | DRUG | Pharmaceutical form:solution Route of administration: intramuscular |
| placebo | DRUG | Pharmaceutical form:solution Route of administration: intramuscular |
Inclusion criteria: * Age\>40 years * History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings * Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial inde...