Status:
COMPLETED
Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
Lead Sponsor:
Sanofi
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery...
Detailed Description
Screening period of 30 days before dosing. Patients receive a single administration or repeated (2) administrations (with a 2-week interval) of NV1FGF. Patients are then followed for a period of 6 mon...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Severe PAOD defined as Rutherford's Grade II, category 4 or Grade III, category 5 and 6
- Pain at rest for at least 2 weeks duration and/or trophic lesions for at least the previous 14 days with no signs of healing (no reduction in ulcer size or depth)
- Objective evidence of peripheral vascular disease (resting Ankle Brachial Index \< 0.4 and/or resting Toe Brachial Index \< 0.3 and/or metatarsal Peripheral Vascular Resistance flat or barely pulsatile in the diseased limb on 2 consecutive examinations performed at least 2 weeks apart)
- Angiographic demonstration of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries
- Poor candidate for surgical intervention or revascularization procedures (no tibial artery incontinuity as defined from mid-leg distance from the foot and no autologous tissue available)
- Exclusion criteria :
- Previous or current history of malignant disease. Patients who had successful tumor resection more than 10 years prior to inclusion into the study and had no recurrence and patients who had curatively resected basal/squamous cancer of the skin were allowed for inclusion
- Abnormal chest X-ray with suspected malignant tumor presence
- Positive stool hemoccult (expect if due to hemorrhoids)
- Positive Prostate Specific Antigen for men with suspected malignant tumor presence
- Abnormal mammography for women with suspected malignant tumor presence
- Papanicolaou smear (for women) of Class IV or Class V characterization
- Proliferative retinopathy
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2001
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01157156
Start Date
June 1 1999
End Date
September 1 2001
Last Update
July 5 2010
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Minneapolis, Minnesota, United States
2
Tempere, Finland