Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication (TALISMAN 211)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Drug: placebo; Drug: XRP0038 (NV1FGF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01157871

PM211 (Other Identifier)

ACT6141

Details and patient eligibility

About

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.

Full description

Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.

Enrollment: 36 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

placebo

Experimental group

Description:

4 administrations at 2-week interval of placebo solution

Treatment:

Drug: placebo

NV1FGF 16 mg

Experimental group

Description:

4 administrations at 2-week interval of 4mg at each administration

Treatment:

Drug: XRP0038 (NV1FGF)

NV1FGF 32 mg

Experimental group

Description:

4 administrations at 2-week interval of 8mg at each administration

Treatment:

Drug: XRP0038 (NV1FGF)