Transplantation Using Hepatitis C Positive Donors A Safety Trial

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    40
  • sponsor
    Jordan Feld
Updated on 23 January 2021
antiviral drugs
pibrentasvir
glecaprevir

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.

Description

The investigators aim to transplant 40 recipients with end-stage organ disease (20 lung, and 20 other organs) using organs from HCV+ donors. Lungs to be used for transplantation will be exposed to ex vivo lung perfusion with use of ultraviolet C light during perfusion if clinically indicated for lung-related outcomes (ie. not determined by the study investigators). Ex vivo organ perfusion will not be used for other organs. Recipients who are scheduled to receive an HCV-infected organ will receive glecaprevir (300mg)/pibrentasvir (120mg) supplied as three fixed-dose combination tablets once a day starting prior to the transplant as soon the patient is in the hospital and it is confirmed that the transplant is proceeding. HCV treatment will continue for 7 days post-transplant (total 8 doses). Recipients will also receive ezetimibe (10 mg) once daily starting at the same time as G/P and continued until 7 days post-transplant. Recipients will have blood samples taken daily for the first 2 weeks and then weekly until 12 weeks post-transplant for HCV PCR (with additional final sample taken at 6 months post-transplant). The investigators hypothesize that HCV transmission to recipients will be prevented by the use of potent DAA prophylaxis plus ezetimibe with or without ex vivo organ perfusion in the immediate peri-operative period.

Details
Condition Hepatitis C, Hepatitis C virus, Kidney Transplant Infection, Lung Transplant Infection, Heart Transplant Infection, Kidney Pancreas Infection
Treatment Ezetimibe 10Mg Oral Tablet, Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet, Ex Vivo Lung Perfusion, Ex Vivo Lung Perfusion
Clinical Study IdentifierNCT04017338
SponsorJordan Feld
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Heart Transplant Infection or Kidney Transplant Infection or Kidney Pancreas Infection or Lung Transplant Infection or Hepatitis C virus or Hepatitis ...?
Do you have any of these conditions: Hepatitis C virus or Kidney Pancreas Infection or Lung Transplant Infection or Kidney Transplant Infection or Heart Transplant Infection or Hepatitis ...?
Recipients listed for kidney, kidney-pancreas, pancreas transplant alone, heart, or lung transplant
HCV NAT negative
Provides written informed consent

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
Clear my responses

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