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Transplantation Using Hepatitis C Positive Donors, A Safety Trial

NCT04017338 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-12

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet

A potent and effective antiviral medication that has recently been approved for use in Canada with over 99% cure rates.

DRUG

Ezetimibe 10Mg Oral Tablet

A cholesterol-lowering medication that also blocks entry of HCV into liver cells.

DEVICE

Ex Vivo Lung Perfusion

A technology that allows for the assessment and treatment of lungs prior to transplant.

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER

  • Jordan Feld

    lead OTHER

Principal Investigators

  • Jordan Feld, MD, MPH · University Health Network Toronto General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2020-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017338 on ClinicalTrials.gov