Actively Recruiting
Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
Led by Baylor Research Institute · Updated on 2026-01-22
15
Participants Needed
3
Research Sites
458 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
CONDITIONS
Official Title
Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and capable of providing written informed consent
- Age 18 years or older
- Listed for isolated orthotopic heart transplant
- HCV seronegative or, if previously HCV seropositive, must be PCR negative on at least 2 tests after cleared infection with last antiviral dose at least 12 weeks ago
You will not qualify if you...
- Listed for combined organ transplant
- History of HCV viremia unless cured (SVR-12)
- Hepatitis B surface antigen positive or detectable hepatitis B DNA unless vaccination effect
- Cirrhosis confirmed by liver biopsy
- Portal hypertension or esophageal varices
- ALT and AST levels greater than 3 times upper limit unless from non-liver sources
- History of prior solid organ transplant
- Pregnant individuals
- History of HIV infection
- Severe renal disease requiring dialysis or creatinine clearance less than 30 ml/min/1.73m2
- Undergoing or planned immune desensitization therapy
- Positive or predicted positive cross-match
- Unwilling to notify sexual partners about trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Duke University Medical Center
Durham, North Carolina, United States, 27705
Active, Not Recruiting
3
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
A
Aayla Jamil, MBBS MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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