Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-02 @ 12:18 AM
Study NCT ID:
NCT04125732
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2019-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2019-10-04', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint (adverse events)', 'timeFrame': '6 months', 'description': 'Safety, as assessed by adverse events and serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint (Exercise tolerance test)', 'timeFrame': '6 months', 'description': 'Exercise tolerance test'}, {'measure': 'Secondary Endpoint (Seattle Angina Questionnaire)', 'timeFrame': '6 months', 'description': 'Seattle Angina Questionnaire'}, {'measure': 'Secondary Endpoint (Canadian Cardiovascular Society angina class)', 'timeFrame': '6 months', 'description': 'Canadian Cardiovascular Society angina class'}, {'measure': 'Secondary Endpoint (Angina episodes)', 'timeFrame': '6 months', 'description': 'Angina episodes'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Refractory angina', 'Coronary Artery Disease', 'Gene Therapy'], 'conditions': ['Coronary Artery Disease', 'Ischemia', 'Angina Refractory', 'Cardiovascular Diseases', 'Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '16791287', 'type': 'BACKGROUND', 'citation': 'Stewart DJ, Hilton JD, Arnold JM, Gregoire J, Rivard A, Archer SL, Charbonneau F, Cohen E, Curtis M, Buller CE, Mendelsohn FO, Dib N, Page P, Ducas J, Plante S, Sullivan J, Macko J, Rasmussen C, Kessler PD, Rasmussen HS. Angiogenic gene therapy in patients with nonrevascularizable ischemic heart disease: a phase 2 randomized, controlled trial of AdVEGF(121) (AdVEGF121) versus maximum medical treatment. Gene Ther. 2006 Nov;13(21):1503-11. doi: 10.1038/sj.gt.3302802. Epub 2006 Jun 22.'}, {'pmid': '38696284', 'type': 'DERIVED', 'citation': 'Nakamura K, Henry TD, Traverse JH, Latter DA, Mokadam NA, Answini GA, Williams AR, Sun BC, Burke CR, Bakaeen FG, DiCarli MF, Chaitman BR, Peterson MW, Byrnes DG, Ohman EM, Pepine CJ, Crystal RG, Rosengart TK, Kowalewski E, Koch GG, Dittrich HC, Povsic TJ; EXACT Trial Investigators. Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial. Circ Cardiovasc Interv. 2024 May;17(5):e014054. doi: 10.1161/CIRCINTERVENTIONS.124.014054. Epub 2024 May 2.'}, {'pmid': '37503661', 'type': 'DERIVED', 'citation': 'Povsic TJ, Henry TD, Traverse JH, Anderson RD, Answini GA, Sun BC, Arnaoutakis GJ, Boudoulas KD, Williams AR, Dittrich HC, Tarka EA, Latter DA, Ohman EM, Peterson MW, Byrnes D, Pepine CJ, DiCarli MF, Crystal RG, Rosengart TK, Mokadam NA. EXACT Trial: Results of the Phase 1 Dose-Escalation Study. Circ Cardiovasc Interv. 2023 Aug;16(8):e012997. doi: 10.1161/CIRCINTERVENTIONS.123.012997. Epub 2023 Jul 28.'}, {'pmid': '34224684', 'type': 'DERIVED', 'citation': 'Povsic TJ, Henry TD, Ohman EM, Pepine CJ, Crystal RG, Rosengart TK, Reinhardt RR, Dittrich HC, Traverse JH, Answini GA, Mokadam NA. Epicardial delivery of XC001 gene therapy for refractory angina coronary treatment (The EXACT Trial): Rationale, design, and clinical considerations. Am Heart J. 2021 Nov;241:38-49. doi: 10.1016/j.ahj.2021.06.013. Epub 2021 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).', 'detailedDescription': 'This is a Phase 1/2, first-in-human, multicenter, open-label, single arm dose escalation trial of XC001. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 32 additional subjects. XC001 will be administered by a transthoracic epicardial procedure. Safety will be the focus for the initial 6 months after XC001 administration followed by one safety focused telephone evaluation at Month 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, age 18 to 80 years\n* Diagnosis of chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft or percutaneous coronary intervention\n* Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina Pectoris\n* Adequate hematologic (hemoglobin ≥ 10 g/dL, absolute neutrophil count \\> 1.2 × 10\\^3 per μL and platelet count ≥ 75,000 per μL), hepatic (alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN; total bilirubin ≤ 2 x ULN), and renal function (glomerular filtration rate \\> 29 mL/minute/1.73 m2)\n* Adequate birth control if of child-bearing potential\n* Must be willing and able to provide informed consent\n\nExclusion Criteria:\n\n* ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days\n* New York Heart Association Function Class III or IV or left ventricular ejection fraction \\< 25% within the 6 weeks prior to the screening visit\n* HbA1c ≥ 8.5%, SBP \\<90 or \\>180 mmHg, DBP \\>100 mmHg\n* Other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study'}, 'identificationModule': {'nctId': 'NCT04125732', 'acronym': 'EXACT', 'briefTitle': 'Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)', 'organization': {'class': 'INDUSTRY', 'fullName': 'XyloCor Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human VEGF, to the Ischemic Myocardium of Subjects With Angina Pectoris', 'orgStudyIdInfo': {'id': 'XC001-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AdVEGFXC1 at 1x10^9 vp', 'interventionNames': ['Biological: AdVEGFXC1']}, {'type': 'EXPERIMENTAL', 'label': 'AdVEGFXC1 at 1x10^10 vp', 'interventionNames': ['Biological: AdVEGFXC1']}, {'type': 'EXPERIMENTAL', 'label': 'AdVEGFXC1 at 4x10^10 vp', 'interventionNames': ['Biological: AdVEGFXC1']}, {'type': 'EXPERIMENTAL', 'label': 'AdVEGFXC1 at 1x10^11 vp', 'interventionNames': ['Biological: AdVEGFXC1']}], 'interventions': [{'name': 'AdVEGFXC1', 'type': 'BIOLOGICAL', 'otherNames': ['XC001'], 'description': 'AdVEGFXC1 at one of 4 doses', 'armGroupLabels': ['AdVEGFXC1 at 1x10^10 vp', 'AdVEGFXC1 at 1x10^11 vp', 'AdVEGFXC1 at 1x10^9 vp', 'AdVEGFXC1 at 4x10^10 vp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiology Research Associates', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'James A. Haley VA Medical Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital / The Lindner Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Health Network', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Heart Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XyloCor Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}