Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease (TALISMAN 201)

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: NCT00368797
Recruitment Status : Completed
First Posted : August 25, 2006
Last Update Posted : November 18, 2008
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Brief Summary:
This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was assessed by the complete healing of at least one ulcer in the treated limb, 25 week post-baseline and secondary by the rate of amputation and death.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Study Start Date : March 2002
Primary Completion Date : April 2005
Study Completion Date : April 2005

Primary Outcome Measures :
  1. Primary efficacy parameter: ulcer healing.
  2. Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.

Secondary Outcome Measures :
  1. Hemodynamic parameters:ABI, TcPO2
  2. Pain
  3. Amputation (Date of amputation, Indication for amputation, amputation level (minor and major)
  4. Death

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients with severe Peripheral Artery Occlusive Disease defined as Rutherford's Grade III, category 5 or 6, or Fontaine's stage IV.
  • Trophic lesions with no signs of healing (no reduction in ulcer size or depth) for at least 2 weeks prior to first study treatment administration (Day 1).
  • Patients with objective evidence of peripheral vascular disease (resting ankle pressure < 70 mmHg and/or toe pressure < 50 mmHg, and/or resting ankle-brachial index (ABI) < 0.4 and/or resting toe-brachial index (TBI) < 0.3 and/or metatarsal pulse volume recording (PVR) flat or barely pulsatile) in the diseased limb on two consecutive examinations performed at least 1 week apart.
  • Demonstration or documentation (historical data not older than 6 months prior to first study treatment administration) of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries as assessed by angiography.
  • Life expectancy > 6 months from the first study treatment administration.
  • Poor/not candidates for revascularization (patients suitable for revascularization but with a high risk of failure/ amputation/ or patients not suitable for revascularization).

Exclusion Criteria:

  • Previous or current history of malignant disease. Patients who had successful tumor resection or radio-chemotherapy more than 5 years prior to inclusion in the study and no recurrence will be allowed for inclusion.
  • Suspicion of malignant disease (abnormal X ray,positive. stool hemoccult, positive Prostate Specific Antigen , abnormal mammography, papanicolaou smear of Class IV or Class V characterization.
  • Lower extremity surgery : bypass/angioplasty of the leg to be treated within 2 months prior to the first administration of study treatment (Day 1).
  • Active proliferative retinopathy.
  • Buerger's disease

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): NCT00368797

Ghent University Hospital
Gent, Belgium
Hôpital Européen Georges Pompidou
Paris, France
Klinikum Karlsbad-Langensteinbach
Karlsbad, Germany
Istituto Dermopatico dell'Immacolata
Roma, Italy
Bern, Switzerland
United Kingdom
St George's Hospital
London, United Kingdom
Sponsors and Collaborators
Principal Investigator: Sigrid NIKOL, Prof. Universitätsklinikum Münster

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00368797     History of Changes
Other Study ID Numbers: DFI6143
First Posted: August 25, 2006    Key Record Dates
Last Update Posted: November 18, 2008
Last Verified: November 2008

Keywords provided by Sanofi:
Gene Therapy

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases