Transplantation Using Hepatitis C Positive Donors, A Safety Trial

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jordan Feld
• Collaborator: University Health Network, Toronto
• Treatments: Antiviral Agents; Ezetimibe

Criteria

Donor Inclusion Criteria:

• Age <70

• NAT+ HCV donor

Donor Exclusion Criteria:

• HIV positive or HTLV 1/2 positive

• Hepatitis B surface Antigen positive

• Any medical issues in the donor that would normally clinically exclude the donor (e.g. history of cancer, evidence of organ dysfunction, etc)

• Age>70

Recipient Inclusion Criteria:

• Recipients listed for kidney, kidney-pancreas, pancreas transplant alone, heart, or lung transplant

• HCV NAT negative

• Provides written informed consent

Recipient Exclusion Criteria:

• Chronic liver disease with > stage 2 fibrosis

• Participating in another interventional clinical trial

• Recipient listed for liver transplant

• Known allergy or contraindication to Glecaprevir/Pibrentasvir or ezetimibe