Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions (TAMARIS)
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|ClinicalTrials.gov Identifier: NCT00566657|
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : May 2, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Diseases||Biological: riferminogene pecaplasmid Biological: Placebo (for riferminogene pecaplasmid)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||525 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||November 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2012|
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
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
- Time to major amputation of the treated leg or death from any cause, whichever comes first [ Time Frame: From randomization up to 12 months ]
- Time to first major amputation of the treated leg [ Time Frame: From randomization up to 12 months ]
- Time to death from any cause [ Time Frame: From randomization up to 12 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566657
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|Study Director:||ICD CSD||Sanofi|