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

Primary Purpose

Peripheral Vascular Diseases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
riferminogene pecaplasmid
Placebo (for riferminogene pecaplasmid)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring Critical Limb Ischemia, Peripheral Artery Disease, Plasmid based gene therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Riferminogene pecaplasmid

Placebo

Arm Description

4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals

4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals

Outcomes

Primary Outcome Measures

Time to major amputation of the treated leg or death from any cause, whichever comes first

Secondary Outcome Measures

Time to first major amputation of the treated leg
Time to death from any cause
Number of participants with adverse events as a measure of safety

Full Information

First Posted
November 30, 2007
Last Updated
March 30, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00566657
Brief Title
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Acronym
TAMARIS
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
Keywords
Critical Limb Ischemia, Peripheral Artery Disease, Plasmid based gene therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
525 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Riferminogene pecaplasmid
Arm Type
Experimental
Arm Description
4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals
Intervention Type
Biological
Intervention Name(s)
riferminogene pecaplasmid
Other Intervention Name(s)
NV1FGF, XRP0038
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Placebo (for riferminogene pecaplasmid)
Intervention Description
Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated
Primary Outcome Measure Information:
Title
Time to major amputation of the treated leg or death from any cause, whichever comes first
Time Frame
From randomization up to 12 months
Secondary Outcome Measure Information:
Title
Time to first major amputation of the treated leg
Time Frame
From randomization up to 12 months
Title
Time to death from any cause
Time Frame
From randomization up to 12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Buenos AIres
Country
Argentina
Facility Name
Sanofi-Aventis Administrative Office
City
Macquarie Park
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Vienna
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Minsk
Country
Belarus
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Tatari
Country
Estonia
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Athens
Country
Greece
Facility Name
Sanofi-Aventis Administrative Office
City
Causeway Bay
Country
Hong Kong
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Milan
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Tokyo
Country
Japan
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Singapore
Country
Singapore
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Geneva
Country
Switzerland
Facility Name
Sanofi-Aventis Administrative Office
City
Istanbul
Country
Turkey
Facility Name
Sanofi-Aventis Administrative Office
City
Kiev
Country
Ukraine
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford
State/Province
Surrey
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21696982
Citation
Van Belle E, Nikol S, Norgren L, Baumgartner I, Driver V, Hiatt WR, Belch J. Insights on the role of diabetes and geographic variation in patients with critical limb ischaemia. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):365-73. doi: 10.1016/j.ejvs.2011.04.030. Epub 2011 Jun 21.
Results Reference
result
PubMed Identifier
21621834
Citation
Belch J, Hiatt WR, Baumgartner I, Driver IV, Nikol S, Norgren L, Van Belle E; TAMARIS Committees and Investigators. Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011 Jun 4;377(9781):1929-37. doi: 10.1016/S0140-6736(11)60394-2. Epub 2011 May 28.
Results Reference
result

Learn more about this trial

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

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