Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease

Peripheral Arterial Disease Clinical Trial

— TALISMAN 201  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368797
• Other study ID #: DFI6143
• Secondary ID: NV1FGF-PM201
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2006
• Last updated: November 14, 2008
• Start date: March 2002
• Est. completion date: April 2005

Study information

• Verified date: November 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutItaly: Ministry of HealthSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• XRP0038 (NV1FGF)

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Gent
France	Hôpital Européen Georges Pompidou	Paris
Germany	Klinikum Karlsbad-Langensteinbach	Karlsbad
Italy	Istituto Dermopatico dell'Immacolata	Roma
Switzerland	Universitätsklinik	Bern
United Kingdom	St George's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Switzerland,  United Kingdom, 

References & Publications (1)

Nikol S, Baumgartner I, Van Belle E, Diehm C, Visoná A, Capogrossi MC, Ferreira-Maldent N, Gallino A, Wyatt MG, Wijesinghe LD, Fusari M, Stephan D, Emmerich J, Pompilio G, Vermassen F, Pham E, Grek V, Coleman M, Meyer F; TALISMAN 201 investigators. Therap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy parameter: ulcer healing.			No
Primary	Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.
Secondary	Hemodynamic parameters:ABI, TcPO2
Secondary	Pain
Secondary	Amputation (Date of amputation, Indication for amputation, amputation level (minor and major)
Secondary	Death

External Links

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