Coronary Artery Disease Clinical Trial
— EXACTOfficial title:
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
Verified date | January 2024 |
Source | XyloCor Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 41 |
Est. completion date | May 30, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Males and females, age 18 to 80 years - 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 - Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina Pectoris - 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) - Adequate birth control if of child-bearing potential - Must be willing and able to provide informed consent Exclusion Criteria: - 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 - New York Heart Association Function Class III or IV or left ventricular ejection fraction < 25% within the 6 weeks prior to the screening visit - HbA1c = 8.5%, SBP <90 or >180 mmHg, DBP >100 mmHg - Other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study |
Country | Name | City | State |
---|---|---|---|
United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
United States | Emory University | Atlanta | Georgia |
United States | The Christ Hospital / The Lindner Research Center | Cincinnati | Ohio |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | The Ohio State University | Columbus | Ohio |
United States | Cardiology Research Associates | Daytona Beach | Florida |
United States | Duke University | Durham | North Carolina |
United States | University of Florida | Gainesville | Florida |
United States | Houston Methodist | Houston | Texas |
United States | Texas Heart Institute | Houston | Texas |
United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
United States | University of Washington | Seattle | Washington |
United States | Stanford University | Stanford | California |
United States | James A. Haley VA Medical Center | Tampa | Florida |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
XyloCor Therapeutics, Inc. |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Endpoint (adverse events) | Safety, as assessed by adverse events and serious adverse events | 6 months | |
Secondary | Secondary Endpoint (Exercise tolerance test) | Exercise tolerance test | 6 months | |
Secondary | Secondary Endpoint (Seattle Angina Questionnaire) | Seattle Angina Questionnaire | 6 months | |
Secondary | Secondary Endpoint (Canadian Cardiovascular Society angina class) | Canadian Cardiovascular Society angina class | 6 months | |
Secondary | Secondary Endpoint (Angina episodes) | Angina episodes | 6 months |
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