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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00566657




Registration number
NCT00566657
Ethics application status
Date submitted
30/11/2007
Date registered
3/12/2007
Date last updated
2/05/2016

Titles & IDs
Public title
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Scientific 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
Secondary ID [1] 0 0
2006-006277-24
Secondary ID [2] 0 0
EFC6145
Universal Trial Number (UTN)
Trial acronym
TAMARIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - riferminogene pecaplasmid
Other interventions - Placebo (for riferminogene pecaplasmid)

Experimental: Riferminogene pecaplasmid - 4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals

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


Other interventions: 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 interventions: 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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to major amputation of the treated leg or death from any cause, whichever comes first
Timepoint [1] 0 0
From randomization up to 12 months
Secondary outcome [1] 0 0
Time to first major amputation of the treated leg
Timepoint [1] 0 0
From randomization up to 12 months
Secondary outcome [2] 0 0
Time to death from any cause
Timepoint [2] 0 0
From randomization up to 12 months
Secondary outcome [3] 0 0
Number of participants with adverse events as a measure of safety
Timepoint [3] 0 0
From 1st treatment administration up to death, or the earliest of Day 360 or last contact/assessment

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
525
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos AIres
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belarus
State/province [4] 0 0
Minsk
Country [5] 0 0
Belgium
State/province [5] 0 0
Diegem
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Canada
State/province [7] 0 0
Laval
Country [8] 0 0
Chile
State/province [8] 0 0
Santiago
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha
Country [10] 0 0
Denmark
State/province [10] 0 0
Horsholm
Country [11] 0 0
Estonia
State/province [11] 0 0
Tatari
Country [12] 0 0
Finland
State/province [12] 0 0
Helsinki
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Greece
State/province [15] 0 0
Athens
Country [16] 0 0
Hong Kong
State/province [16] 0 0
Causeway Bay
Country [17] 0 0
Hungary
State/province [17] 0 0
Budapest
Country [18] 0 0
Italy
State/province [18] 0 0
Milan
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Mexico
State/province [21] 0 0
Mexico
Country [22] 0 0
Poland
State/province [22] 0 0
Warszawa
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Moscow
Country [24] 0 0
Singapore
State/province [24] 0 0
Singapore
Country [25] 0 0
South Africa
State/province [25] 0 0
Midrand
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Sweden
State/province [27] 0 0
Bromma
Country [28] 0 0
Switzerland
State/province [28] 0 0
Geneva
Country [29] 0 0
Turkey
State/province [29] 0 0
Istanbul
Country [30] 0 0
Ukraine
State/province [30] 0 0
Kiev
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00566657
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries