Status:
COMPLETED
Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
Lead Sponsor:
Sanofi
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Periph...
Eligibility Criteria
Inclusion
- Outpatients with severe Peripheral Artery Occlusive Disease defined as Rutherford's Grade III, category 5 or 6, or Fontaine's stage IV.
- 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 (resting ankle pressure \< 70 mmHg and/or toe pressure \< 50 mmHg, and/or resting ankle-brachial index (ABI) \< 0.4 and/or resting toe-brachial index (TBI) \< 0.3 and/or metatarsal pulse volume recording (PVR) flat or barely pulsatile) in the diseased limb on two consecutive examinations performed at least 1 week apart.
- Demonstration or documentation (historical data not older than 6 months prior to first study treatment administration) 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.
- Life expectancy \> 6 months from the first study treatment administration.
- Poor/not candidates for revascularization (patients suitable for revascularization but with a high risk of failure/ amputation/ or patients not suitable for revascularization).
Exclusion
- Previous or current history of malignant disease. Patients who had successful tumor resection or radio-chemotherapy more than 5 years prior to inclusion in the study and no recurrence will be allowed for inclusion.
- Suspicion of malignant disease (abnormal X ray,positive. stool hemoccult, positive Prostate Specific Antigen , abnormal mammography, papanicolaou smear of Class IV or Class V characterization.
- Lower extremity surgery : bypass/angioplasty of the leg to be treated within 2 months prior to the first administration of study treatment (Day 1).
- Active proliferative retinopathy.
- Buerger's disease
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00368797
Start Date
March 1 2002
End Date
April 1 2005
Last Update
November 18 2008
Active Locations (6)
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1
Ghent University Hospital
Ghent, Belgium
2
Hôpital Européen Georges Pompidou
Paris, France
3
Klinikum Karlsbad-Langensteinbach
Karlsbad, Germany
4
Istituto Dermopatico dell'Immacolata
Roma, Italy