Status:
ACTIVE_NOT_RECRUITING
Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
Lead Sponsor:
Baylor Research Institute
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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 / ve...
Detailed Description
utilizing HCV-positive donors (defined as HCV-NAT positive) for heart transplantation in HCV-negative recipients treated with Epclusa®. Subjects will be identified from the heart transplantation wait...
Eligibility Criteria
Inclusion
- Willing and capable of providing written informed consent
- Age ≥ 18 years
- Listed for isolated orthotopic heart transplant
- HCV seronegative (or, if HCV seropositive, then subject must be PCR negative on at least 2 draws consistent with a spontaneously cleared or fully-treated and cleared prior infection; in this case last anti-HCV antiviral dose must be ≥12 weeks ago and 2 negative titers ≥12 weeks after completion of the antiviral regimen)
Exclusion
- Listed for combined organ transplant
- Any of the following liver disease states, including:
- History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
- Hepatitis B surface Ag positive(unless clinically determined to be previously negative and acutely positive due to vaccination with recombinant surface antigen) or detectable hepatitis B DNA,
- Cirrhosis, as indicated by liver biopsy,
- Portal hypertension as indicated by a hepatic venous pressure gradient \> 5 mm Hg and/or the presence of esophageal varices e.) ALT and AST \> 3x ULN unless adjudicated to be from a non-hepatic cardiac or skeletal muscle source,
- History of prior solid organ transplant
- Pregnant individuals
- History of HIV infection
- History of severe renal disease currently requiring dialysis. Chronic kidney disease with creatinine clearance \<30 ml/min/1.73m2 (by MDRD method) at screening or on last two consecutive measurements before acceptance of transplant organ offer
- Patients who have undergone or who will undergo immune desensitization therapy
- Prospective-positive cross-match or predicted positive cross-match
- Patients unwilling to notify their sexual partner(s) of participation in this trial
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03383419
Start Date
March 20 2018
End Date
December 30 2025
Last Update
October 8 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Duke University Medical Center
Durham, North Carolina, United States, 27705
3
Baylor University Medical Center
Dallas, Texas, United States, 75246