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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157871
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 7, 2010
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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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Occlusive Disease Drug: XRP0038 (NV1FGF) Drug: placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Arm Intervention/treatment
Experimental: placebo
4 administrations at 2-week interval of placebo solution
Drug: placebo

Pharmaceutical form:solution

Route of administration: intramuscular

Experimental: NV1FGF 16 mg
4 administrations at 2-week interval of 4mg at each administration
Drug: XRP0038 (NV1FGF)

Pharmaceutical form:solution

Route of administration: intramuscular

Experimental: NV1FGF 32 mg
4 administrations at 2-week interval of 8mg at each administration
Drug: XRP0038 (NV1FGF)

Pharmaceutical form:solution

Route of administration: intramuscular

Primary Outcome Measures :
  1. Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. NV1FGF DNA 69 base pair (bp) in plasma [ Time Frame: up to week 27 ]
  2. NV1FGF DNA 825 bp in plasma [ Time Frame: up to week 27 ]
  3. FGF-1 in plasma [ Time Frame: up to week 27 ]
  4. Anti-FGF1 antibodies in serum [ Time Frame: up to week 27 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01157871

United States, Minnesota
Minneapolis, Minnesota, United States
Bruxelles, Belgium
Münster, Germany
Bern, Switzerland
Sponsors and Collaborators
Study Director: International Clinical Development Study Director Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: International Clinical Development Study Director, sanofi-aventis Identifier: NCT01157871     History of Changes
Other Study ID Numbers: ACT6141
PM211 ( Other Identifier: Gencell )
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Intermittent Claudication
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Peripheral Vascular Diseases