40 Participants Needed

HCV-Positive Organ Transplant Safety

JF
NK
Overseen ByNellie Kamkar, MSc
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Jordan Feld
Must be taking: Direct-acting antivirals
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

JF

Jordan Feld, MD, MPH

Principal Investigator

University Health Network Toronto General Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplant Antiviral Prophylaxis

Participants receive an initial dose of antiviral prophylaxis using Glecaprevir/Pibrentasvir and ezetimibe prior to transplantation

1 day

Transplantation and Immediate Post-Transplant Treatment

Participants undergo organ transplantation and receive daily doses of Glecaprevir/Pibrentasvir and ezetimibe for 7 days post-transplant

1 week

Follow-up

Participants are monitored for safety, HCV transmission, and organ function with blood samples taken daily for the first 2 weeks and then weekly until 12 weeks post-transplant

12 weeks

Long-Term Follow-up

Participants are monitored for long-term organ function and HCV seroconversion up to 1 year post-transplant

1 year

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Non Randomized InterventionExperimental Treatment3 Interventions

Find a Clinic Near You

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+
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