A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Different Doses and Schedules of Administration of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Severe Peripheral Artery Occlusive Disease
- Sponsor
- Sanofi
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers.
Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD
Investigators
Eligibility Criteria
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)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.
Secondary Outcomes
- evaluate the biodistribution of NV1FGF and to measure serum levels of antibodies against FGF-1