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
  Purpose

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.

Condition Intervention Phase
Peripheral Vascular Diseases
Biological: riferminogene pecaplasmid
Biological: Placebo (for riferminogene pecaplasmid)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 525
Study Start Date: November 2007
Study Completion Date: August 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Riferminogene pecaplasmid
4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals
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
Placebo Comparator: Placebo
4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals
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


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT00566657

  Show 32 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00566657     History of Changes
Other Study ID Numbers: EFC6145, 2006-006277-24
Study First Received: November 30, 2007
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Russia: Ministry of Health of the Russian Federation

Keywords provided by Sanofi:
Critical Limb Ischemia
Peripheral Artery Disease
Plasmid based gene therapy

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

ClinicalTrials.gov processed this record on October 16, 2014