HCV-Positive Organ Transplant Safety

Overseen By Nellie Kamkar, MSc

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Jordan Feld

Must be taking: Direct-acting antivirals

Disqualifiers: Chronic liver disease, other trial, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jordan Feld, MD, MPH

Principal Investigator

University Health Network Toronto General Hospital

Eligibility Criteria

This trial is for individuals under the age of 70 who need an organ transplant and are willing to receive organs from donors with Hepatitis C, using antiviral prophylaxis. It's not suitable for those outside this age range or those who may have conditions that could interfere with the study.

Inclusion Criteria

I am younger than 70 years old.

Treatment Details

Interventions

• Ezetimibe
• Glecaprevir/Pibrentasvir

Trial Overview The trial tests if it's safe to transplant organs from Hepatitis C positive donors into recipients without the virus by giving them antivirals (Glecaprevir/Pibrentasvir) and a cholesterol drug (Ezetimibe) that also blocks HCV entry into cells before and after surgery.

Participant Groups

Group I: Non Randomized Intervention Experimental Treatment 3 Interventions

Intervention description: recipients on the wait-list for lung, heart, kidney, and/or pancreas transplants will all receive antiviral treatment in the form of 8 total doses of oral tablets. Lung recipients will also receive donor lungs that are treated with normothermic EVLP (details of both described below). Drug: All recipients will receive glecaprevir (300mg)/pibrentasvir (120mg) supplied as three tablets per dose 6-12 hours prior to transplant, and for 7 days post-transplant. Other Names: Maviret. Patients will also receive ezetimibe (10mg), supplied as one tablet per dose to be taken at the same time as Maviret tablets (6-12 hours prior to transplant in addition to 7 daily doses post-transplant). Ex Vivo Lung Perfusion (EVLP): Normothermic EVLP is a method of donor lung preservation, assessment, treatment, and repair of injured organs. This method allows donor lungs to be treated for at least 12h under protective physiological conditions. Other names: Normothermic EVLP.

Who Is Running the Clinical Trial?

Jordan Feld

Lead Sponsor

Trials

2

Recruited

3,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+