Status:
COMPLETED
Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)
Lead Sponsor:
XyloCor Therapeutics, Inc.
Conditions:
Coronary Artery Disease
Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04125732
Start Date
January 24 2020
End Date
May 30 2023
Last Update
January 30 2024
Active Locations (16)
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1
Stanford University
Stanford, California, United States, 94305
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Cardiology Research Associates
Daytona Beach, Florida, United States, 32117
4
University of Florida
Gainesville, Florida, United States, 32610