Severe Peripheral Artery Occlusive Disease Clinical Trial
— TALISMAN202Official title:
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.
| Verified date | June 2017 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 71 |
| Est. completion date | July 2005 |
| Est. primary completion date | July 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: 1. Informed consent was to be signed before proceeding with any study procedure. 2. Patients with severe PAD. 3. 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). 4. Patients with objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart. 5. 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) 6. 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 7. Poor/not candidates for revascularization Exclusion criteria 1. Previous or current history of malignant disease. 2. Positive cancer screening (liver, prostate, colon, cervix, breast, lung) 3. 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]). 4. Patients planned to undergo amputation of target limb within 1 month following the first administration of study treatment. 5. Patients with a history of severe renal failure. 6. Creatinine >2.0 mg/dL (176 µmol/L) or estimated creatinine clearance <30 mL. 7. Serious concomitant medical conditions not adequately controlled (other than severe PAD), 8. Buerger's disease. 9. Patients in dialysis. 10. Active proliferative retinopathy 11. 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. 12. Previous treatment with any angiogenic growth factor. 13. Positive serology for HIV 1 or 2. 14. Participation in clinical trials of non-approved experimental agents within 4 weeks before study entry. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Sanofi-Aventis Administrative Office | Bridgewater | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States,
Henry TD, Mendelsohn F, Comerota A, Pham E, Grek V, Coleman M, Meyer F, Annex B Dose and regimen effects of intramuscular NV1FGF in patients with critical limb ischemia: A randomized, double-blind, placebo controlled study. Eur H J 2006, 27 Suppl 1 Abs P1
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD. | |||
| Secondary | evaluate the biodistribution of NV1FGF and to measure serum levels of antibodies against FGF-1 |