Status:
COMPLETED
Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation
Lead Sponsor:
Sanofi
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV...
Detailed Description
Screening of 1 to 4 weeks before study drug administration; Single study drug administration 3 to 8 days before planned amputation; 6 months of follow up
Eligibility Criteria
Inclusion
- Subjects with prior decision for amputation above the ankle because of severe PAOD
- Males or females above 18 years
- Females must be either:
- Non pregnant, non lactating , having practicing a medically accepted method of birth control for more than 2 months prior screening visit;
- or surgically sterilized (tubal ligation or hysterectomy)
- or post menopausal for at least one year
Exclusion
- Subjects with urgent need for amputation that cannot await until completion of the screening period (up to 4 weeks), added to the minimum required 48 hours between study test medication administration and tissue sample collection
- Previous or current history of malignant disease (subjects with successful tumor resection more than 5 years -without any recurrence- prior to study start could be enrolled)
- Abnormal Chest X-ray or mammography with suspicion of malignant disease
- Positive stool hemoccult (except in case of hemorrhoids or any other identified cause with no malignancy origin)
- Men with positive Prostate Specific Antigen (PSA) (above 2.5 ng/ml in subjects \< 50 years and above 5 ng/ml in subjects above 50 years)
- Females with Papanicolaou smear of Class IV or Class V characterization
- Serious concomitant medical conditions not adequately controlled
- Alcohol or drug abuse
- Active proliferate retinopathy defined by the presence of new vessel formation and scarring
- Participation in clinical trials of non-approved experimental agents within four weeks before study entry;
- Positive serology for HIV1 or 2
- Creatinine above 2.0 mg/dl (176 µmol/l), unless the subject is on hemodialysis / peritoneal dialysis and diagnosed with complete and irreversible renal failure or end-stage renal disease (ESRD)
- Subjects who had a stroke or a neurological deficit presumably due to a stroke, within 3 months prior to study treatment (Amendment #1)
- Alpha-fetoprotein (AFP) in serum \> 15 µg/l, unless liver ultrasound ruled out any malignant disease
- Positive serology for hepatitis B or C, unless liver ultrasound ruled out any malignant disease.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01157143
Start Date
January 1 2002
End Date
October 1 2003
Last Update
July 5 2010
Active Locations (2)
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1
Minneapolis, Minnesota, United States
2
Bern, Switzerland