Transplantation Using Hepatitis C Positive Donors, A Safety Trial

Sponsor
Jordan Feld
Study ID
NCT04017338
Phase
PHASE3
Status
Unknown

Conditions

  • Heart Transplant Infection
  • Hepatitis C
  • Kidney Pancreas Infection
  • Kidney Transplant Infection
  • Lung Transplant Infection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet — DRUG
    A potent and effective antiviral medication that has recently been approved for use in Canada with over 99% cure rates.
  • Ezetimibe 10Mg Oral Tablet — DRUG
    A cholesterol-lowering medication that also blocks entry of HCV into liver cells.
  • Ex Vivo Lung Perfusion — DEVICE
    A technology that allows for the assessment and treatment of lungs prior to transplant.

Study Details

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.

Key Dates

Start date
Aug 6, 2018
Status verified
Jul 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Non Randomized Intervention
    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.

Primary Outcome Measure

Post-transplant Survival [Safety] [ Time Frame: 6 months ]

Central Contacts

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