Recruiting
Phase 3

Hepatitis C Transplantation

Sponsor:

Jordan Feld

Code:

NCT04017338

Conditions

Lung Transplant Infection

Heart Transplant Infection

Kidney Transplant Infection

Kidney Pancreas Infection

Hepatitis C

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet

Ezetimibe 10Mg Oral Tablet

Ex Vivo Lung Perfusion

Study Details

Brief 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

Study ID

NCT04017338

Start date

Aug 6, 2018

Status verified date

Jul, 2019

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Ezetimibe 10Mg Oral Tablet

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

Ex Vivo Lung Perfusion

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

Primary outcome measure

  • Post-transplant Survival [Safety] [ Time Frame: 6 months ]
  • Incidence of HCV transmission [Safety] [ Time Frame: 6 months ]
  • Incidence of treatment-emergent adverse events [Safety and Tolerability] [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Jordan Feld, MD, MPH

416-340-4800Jordan.Feld@uhn.ca

Nellie Kamkar, MSc

416-340-4800Nellie.Kamkar@uhn.ca

Locations

University Health Network Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Jordan Feld, MD, MPH

416-340-4800Jordan.Feld@uhn.ca

Nellie Kamkar, MSc

416-340-4800Nellie.Kamkar@uhn.ca

More Information

Sponsor

Jordan Feld

Last update posted

Jul 12, 2019

Last verified

Jul, 2019

Keywords

  • Organ Transplant
  • Hepatitis C Virus
  • Direct-Acting Antivirals (DAAs)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jordan Feld on 2019-07-12.