Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions (TAMARIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00566657
First received: November 30, 2007
Last updated: July 31, 2013
Last verified: July 2013

November 30, 2007
July 31, 2013
November 2007
August 2010   (final data collection date for primary outcome measure)
Time to major amputation of the treated leg or death from any cause, whichever comes first [ Time Frame: From randomization up to 12 months ] [ Designated as safety issue: No ]
Time to major amputation of the treated leg or death from any cause, whichever comes first [ Time Frame: over 12 months ]
Complete list of historical versions of study NCT00566657 on ClinicalTrials.gov Archive Site
  • Time to first major amputation of the treated leg [ Time Frame: From randomization up to 12 months ] [ Designated as safety issue: No ]
  • Time to death from any cause [ Time Frame: From randomization up to 12 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety [ Time Frame: From 1st treatment administration up to death, or the earliest of Day 360 or last contact/assessment ] [ Designated as safety issue: Yes ]
  • Adverse events
  • Laboratory parameters
Not Provided
Not Provided
 
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions

Primary objective is to demonstrate the superiority of riferminogene pecaplasmid over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.

Secondary objectives are to evaluate:

  • The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
  • The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
  • The safety of riferminogene pecaplasmid in the study population.

The study consists in 6-week treatment then a follow-up period up to 12 months. A follow-up contact is then scheduled 6 months later.

Per protocol amendment a 18-month long-term safety survey was added.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Peripheral Vascular Diseases
  • Biological: riferminogene pecaplasmid

    Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid

    Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated

    Other Name: XRP0038/NV1FGF
  • Biological: Placebo (for riferminogene pecaplasmid)

    Formulation: 5 ml glass vials containing 2,5 ml placebo

    Route: IM injection of 2.5 mL in the ischemic leg to be treated

  • Experimental: Riferminogene pecaplasmid
    4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals
    Intervention: Biological: riferminogene pecaplasmid
  • Placebo Comparator: Placebo
    4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals
    Intervention: Biological: Placebo (for riferminogene pecaplasmid)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
525
August 2012
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene);
  • With objective evidence of CLI such as ankle systolic pressure <70 mmHg and/or toe systolic pressure <50 mmHg or transcutaneous oxygen pressure (TcPO2) <30 mmHg;
  • Unsuitable for standard revascularization of his/her peripheral arterial disease;
  • Having a negative screening for cancer.

Exclusion Criteria:

  • Previous major amputation on the leg to be treated or planned major amputation within the first month following randomization;
  • Known Buerger's disease;
  • Successful lower extremity revascularization procedure within 3 months prior randomization;
  • Uncontrolled blood pressure defined as systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg despite adequate antihypertensive treatment;
  • Acute cardiovascular events within 3 months prior to randomization;
  • Active proliferative retinopathy and severe macular oedema;
  • Previous or current history of malignant disease within the past 5 years;
  • Previous treatment with systemic angiogenic factors or with stem cells therapy;
  • Pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control. Man not following effective contraceptive method with his partner of childbearing potential during the course of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom
 
NCT00566657
EFC6145, 2006-006277-24
Yes
Sanofi
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP