Status:
COMPLETED
Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Lead Sponsor:
Sanofi
Conditions:
Severe Peripheral Artery Occlusive Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a m...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent was to be signed before proceeding with any study procedure.
- Patients with severe PAD.
- Trophic lesions with no signs of healing (no reduction in ulcer size or depth) for at least 2 weeks prior to first study treatment administration (Day 1).
- Patients with objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart.
- Demonstration or documentation of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries as assessed by angiography or magnetic resonance angiography (MRA)
- Transcutaneous oxygen pressure (TcPO2): mean resting supine TcPO2 of the foot of ≤40 mmHg based on 2 separate measures performed at least 1 week apart
- Poor/not candidates for revascularization
- Exclusion criteria
- Previous or current history of malignant disease.
- Positive cancer screening (liver, prostate, colon, cervix, breast, lung)
- Successful lower extremity surgery (bypass/angioplasty of the leg to be treated) within 3 months prior to the first administration of study treatment \[Day 1\]).
- Patients planned to undergo amputation of target limb within 1 month following the first administration of study treatment.
- Patients with a history of severe renal failure.
- Creatinine \>2.0 mg/dL (176 µmol/L) or estimated creatinine clearance \<30 mL.
- Serious concomitant medical conditions not adequately controlled (other than severe PAD),
- Buerger's disease.
- Patients in dialysis.
- Active proliferative retinopathy
- Patients who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment.
- Previous treatment with any angiogenic growth factor.
- Positive serology for HIV 1 or 2.
- Participation in clinical trials of non-approved experimental agents within 4 weeks before study entry.
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00798005
Start Date
June 1 2002
End Date
July 1 2005
Last Update
June 8 2017
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States