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Hepatitis C Positive Liver Transplants for Liver Transplant Recipients

Phase 2

Waitlist Available

Led By Naudia Jonassaint, MD

Research Sponsored by Naudia Jonassaint. MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with end-stage liver disease listed for liver transplantation at UPMC.

Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation

Must not have

Known ongoing therapy for HCV

Known allergy to sofosbuvir/velpatasvir

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of transplanting livers from donors who are either positive or negative for the Hepatitis C virus. Treatment and prophylaxis will be administered to the recipients based on the donor's status.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from sofosbuvir/velpatasvir include headache, fatigue, nausea, insomnia, and sometimes more serious reactions like slowed heart rate or liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on the liver transplant list at UPMC for end-stage liver disease.

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I can travel to UPMC for follow-up visits for at least a year after my transplant.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for hepatitis C.

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I am allergic to sofosbuvir/velpatasvir.

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I have used amiodarone for atrial fibrillation in the last year.

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I have received an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

HCV free at 1 year

Secondary study objectives

All-cause mortality

Incidence of allograft rejection

Incidence of graft loss

+2 more

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT03235154

18%

GI distress

Suicidal Ideation

Fatigue

Scabies

Altered Mental Status

Seizure

Visual Hallucination

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm Intervention

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: HCV seropositive viremic (HCV Ab+/NAT+) donorExperimental Treatment1 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-) donorExperimental Treatment1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Velpatasvir

FDA approved

0 / 7Eligibility criteria met