Status:
COMPLETED
The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
Lead Sponsor:
Fernanda P Silveira, MD, MS
Collaborating Sponsors:
University of Pittsburgh Medical Center
Conditions:
Liver Transplant
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) don...
Detailed Description
This is a prospective, single center, pilot, open-label study of transplantation of livers of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipie...
Eligibility Criteria
Inclusion
- Inclusion criteria (recipients):
- Patients with end-stage liver disease listed for liver transplantation at UPMC.
- Age ≥ 18
- No available living liver donor
- Listed for an isolated liver transplant at UPMC
- Have panel reactive antibody level of \<98%
- Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
- Able to provide informed consent
- Be willing to use a contraceptive method for a year after transplant
- Exclusion criteria (recipients):
- HIV positive
- HCVAb or HCV RNA positive
- Presence of behavioral risk factors for contracting HCV. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting.
- Hepatitis B surface antigen positive
- History of atrial fibrillation requiring the use of amiodarone over the past 12m
- Receipt of prior organ transplant
- Waitlisted for a multi-organ transplant
- Pregnant women
- Known allergy to sofosbuvir/velpatasvir
- Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
- Inclusion criteria (donors):
- HCV antibody positive
- HCV NAT negative or positive
- Exclusion criteria (donors):
- Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)
- Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT)
- Known ongoing therapy for HCV
Exclusion
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03819322
Start Date
August 15 2019
End Date
March 17 2025
Last Update
August 12 2025
Active Locations (1)
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1
UPMC
Pittsburgh, Pennsylvania, United States, 15213