Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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 NV1FGF.

Secondary objectives :

• To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF

• To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site)

• To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site)

• To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma

• To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site

• To collect data from plasma NV1FGF pharmacokinetics

• To evaluate healing of the amputation site

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.