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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00368797
First received: August 24, 2006
Last updated: November 14, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Peripheral Arterial Disease
Drug: XRP0038 (NV1FGF)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Primary efficacy parameter: ulcer healing. [ Designated as safety issue: No ]
  • Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.

Secondary Outcome Measures:
  • Hemodynamic parameters:ABI, TcPO2
  • Pain
  • Amputation (Date of amputation, Indication for amputation, amputation level (minor and major)
  • Death

Enrollment: 125
Study Start Date: March 2002
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368797

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00368797     History of Changes
Other Study ID Numbers: DFI6143, NV1FGF-PM201
Study First Received: August 24, 2006
Last Updated: November 14, 2008
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: Ministry of Health
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi:
Gene Therapy
PAOD
CLI

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

ClinicalTrials.gov processed this record on September 30, 2014