Peripheral Arterial Occlusive Disease
Conditions
Brief summary
The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo. The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.
Detailed description
Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.
Interventions
DRUGXRP0038 (NV1FGF)
Pharmaceutical form:solution Route of administration: intramuscular
DRUGplacebo
Pharmaceutical form:solution Route of administration: intramuscular
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>40 years * History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings * Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) \<0.8 or Systolic ankle pressure (AP) \< 50 mmHg or Systolic toe pressure \<50 mmHg * Patent femoral inflow above the level of injections recently (\<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography
Exclusion criteria
* Evidence of other causes for leg pain other than intermittent claudication. * Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders…) * Pain at rest * Buerger's disease * Positive serology for HIV 1 or 2, positive serology hepatitis B or C. * Subjects with serum creatinine \> 2 mg/dl (176 µmol/l) and subjects on dialysis. * Active proliferative retinopathy defined by the presence of new vessel formation and scarring. * Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment * Previous treatment with any angiogenic growth factor * Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period * Serious concomitant medical conditions not adequately controlled. * Current alcohol or drug abuse The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 | 13 weeks |
Secondary
| Measure | Time frame |
|---|---|
| NV1FGF DNA 69 base pair (bp) in plasma | up to week 27 |
| NV1FGF DNA 825 bp in plasma | up to week 27 |
| FGF-1 in plasma | up to week 27 |
| Anti-FGF1 antibodies in serum | up to week 27 |
Countries
Belgium, Germany, Switzerland, United States
Outcome results
None listed