Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-03 @ 7:45 PM
Study NCT ID:
NCT00566657
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2007-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Malaysia', 'Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554637', 'term': 'riferminogene pecaplasmide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 525}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'dispFirstSubmitDate': '2016-03-30', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-30', 'studyFirstSubmitDate': '2007-11-30', 'dispFirstSubmitQcDate': '2016-03-30', 'studyFirstSubmitQcDate': '2007-11-30', 'dispFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to major amputation of the treated leg or death from any cause, whichever comes first', 'timeFrame': 'From randomization up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Time to first major amputation of the treated leg', 'timeFrame': 'From randomization up to 12 months'}, {'measure': 'Time to death from any cause', 'timeFrame': 'From randomization up to 12 months'}, {'measure': 'Number of participants with adverse events as a measure of safety', 'timeFrame': 'From 1st treatment administration up to death, or the earliest of Day 360 or last contact/assessment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Critical Limb Ischemia', 'Peripheral Artery Disease', 'Plasmid based gene therapy'], 'conditions': ['Peripheral Vascular Diseases']}, 'referencesModule': {'references': [{'pmid': '21696982', 'type': 'RESULT', '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.'}, {'pmid': '21621834', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary objectives are to evaluate:\n\n* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;\n* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;\n* The safety of riferminogene pecaplasmid in the study population.', 'detailedDescription': '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.\n\nPer protocol amendment a 18-month long-term safety survey was added.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene);\n* 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;\n* Unsuitable for standard revascularization of his/her peripheral arterial disease;\n* Having a negative screening for cancer.\n\nExclusion Criteria:\n\n* Previous major amputation on the leg to be treated or planned major amputation within the first month following randomization;\n* Known Buerger's disease;\n* Successful lower extremity revascularization procedure within 3 months prior randomization;\n* Uncontrolled blood pressure defined as systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg despite adequate antihypertensive treatment;\n* Acute cardiovascular events within 3 months prior to randomization;\n* Active proliferative retinopathy and severe macular oedema;\n* Previous or current history of malignant disease within the past 5 years;\n* Previous treatment with systemic angiogenic factors or with stem cells therapy;\n* 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.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00566657', 'acronym': 'TAMARIS', 'briefTitle': 'Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EFC6145'}, 'secondaryIdInfos': [{'id': '2006-006277-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Riferminogene pecaplasmid', 'description': '4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals', 'interventionNames': ['Biological: riferminogene pecaplasmid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals', 'interventionNames': ['Biological: Placebo (for riferminogene pecaplasmid)']}], 'interventions': [{'name': 'riferminogene pecaplasmid', 'type': 'BIOLOGICAL', 'otherNames': ['NV1FGF', 'XRP0038'], 'description': 'Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid\n\nRoute: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated', 'armGroupLabels': ['Riferminogene pecaplasmid']}, {'name': 'Placebo (for riferminogene pecaplasmid)', 'type': 'BIOLOGICAL', 'description': 'Formulation: 5 ml glass vials containing 2,5 ml placebo\n\nRoute: IM injection of 2.5 mL in the ischemic leg to be treated', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bridgewater', 'state': 'New Jersey', 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