Clinical trial NCT01157871: Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication
Official title: Double-blind, Randomized, Placebo-controlled, Parallel Group and Dose-finding, Multicentric, Safety and Efficacy Study With Intramuscular Injections of NV1FGF in Subjects With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-07-07
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13
timeFrame: 13 weeks
Secondary outcomes:
measure: NV1FGF DNA 69 base pair (bp) in plasma
timeFrame: up to week 27
measure: NV1FGF DNA 825 bp in plasma
timeFrame: up to week 27
measure: FGF-1 in plasma
timeFrame: up to week 27
measure: Anti-FGF1 antibodies in serum
timeFrame: up to week 27
Other outcomes:
Locations:
city: Minneapolis
country: United States
state: Minnesota
city: Bruxelles
country: Belgium
city: Münster
country: Germany
city: Bern
country: Switzerland
Study officials:
affiliation: Sanofi
name: International Clinical Development Study Director
role: STUDY_DIRECTOR
References:
citation: Niebuhr A, Henry T, Goldman J, Baumgartner I, van Belle E, Gerss J, Hirsch AT, Nikol S. Long-term safety of intramuscular gene transfer of non-viral FGF1 for peripheral artery disease. Gene Ther. 2012 Mar;19(3):264-70. doi: 10.1038/gt.2011.85. Epub 2011 Jun 30.