Transplantation Using Hepatitis C Positive Donors, A Safety Trial
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
The success of transplantation is significantly hindered by the lack of sufficient number of
available donors. Many potential donor organs cannot be utilized in clinical transplantation
because donors have chronic viral infections such as hepatitis C (HCV) infection. This study
will test the possibility of safely transplanting organs from HCV-infected donors into
HCV-uninfected recipients. Prior to transplantation, recipients will receive an initial dose
of highly effective antiviral prophylaxis using approved direct-acting antivirals (DAAs)
Glecaprevir/Pibrentasvir (G/P) and they will also receive ezetimibe, a cholesterol-lowering
medication that also blocks entry of HCV into liver cells. They will then receive daily
dosing of the same medications for 7 days after transplant. The aim of the study is to show
that transplantation of organs from HCV+ donors is safe in the era of DAAs. The investigators
hypothesize that rates of HCV transmission to recipients will be prevented by the use of DAA
prophylaxis and any HCV transmission that does occur will be readily treatable and curable.
If successful, the knowledge from this study can have a large impact to patients with end
stage organ diseases by providing a large novel source of donors for organ transplantations.