Hepatitis C Positive Liver Transplants for Liver Transplant Recipients

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Naudia Jonassaint. MD

Must not be taking: Amiodarone, Sofosbuvir/Velpatasvir

Disqualifiers: HIV, Hepatitis B, Drug use, others

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

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

73 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the liver transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

Research Team

Fernanda Silviera, MD

Principal Investigator

University of Pittsburgh

Naudia Jonassaint, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 on the UPMC liver transplant waitlist, without HIV or hepatitis B, and no history of multi-organ transplants or certain drug uses. They must be willing to travel for post-transplant care and use contraception for a year.

Inclusion Criteria

Have panel reactive antibody level of <98%

Able to provide informed consent

Listed for an isolated liver transplant at UPMC

Exclusion Criteria

I am currently receiving treatment for hepatitis C.

HCVAb or HCV RNA positive

You are on the waiting list for a transplant involving multiple organs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation and Immediate Post-operative Treatment

Liver transplantation from HCV seropositive donors to HCV seronegative recipients, followed by immediate post-operative treatment with sofosbuvir/velpatasvir for 12 weeks in the prophylaxis arm

12 weeks

Regular monitoring visits

Transmission-triggered Treatment

Monitoring for HCV transmission in recipients of HCVAb+/NAT- donor livers, with treatment initiated upon detection of HCV RNA

Up to 1 year

Regular monitoring visits

Follow-up

Participants are monitored for safety, effectiveness, and virological response after treatment

1 year

Regular follow-up visits

Long-term Follow-up

Monitoring for incidence of graft loss, allograft rejection, and other outcomes

5 years

Treatment Details

Interventions

• Sofosbuvir/Velpatasvir

Trial Overview The study tests if Hepatitis C positive livers can safely be transplanted into patients without Hepatitis C. It involves two approaches: one where treatment starts only if the virus is detected after transplant, and another with immediate preventive treatment.

Participant Groups

Group I: HCV seropositive viremic (HCV Ab+/NAT+) donor Experimental Treatment 1 Intervention

Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

Group II: HCV seropositive non-viremic (HCV Ab+/NAT-) donor Experimental Treatment 1 Intervention

Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated. Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

Who Is Running the Clinical Trial?

Naudia Jonassaint. MD

Lead Sponsor

Trials

1

Recruited

70+

Naudia Jonassaint

Lead Sponsor

Trials

1

Recruited

70+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+