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Hepatitis c donor livers safely transplanted into healthy recipients

NCT ID NCT03819322

Disease control Sponsor: Fernanda P Silveira, MD, MS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether livers from donors with hepatitis C could be safely transplanted into people without hepatitis C. Five patients on the liver transplant waiting list received these livers and were then treated with an antiviral drug to prevent infection. The goal was to see if this approach could expand the donor pool and reduce wait times.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

Aug 2019

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria (recipients): 1. Patients with end-stage liver disease listed for liver transplantation at UPMC. 2. Age ≥ 18 3. No available living liver donor 4. Listed for an isolated liver transplant at UPMC 5. Have panel reactive antibody level of \<98% 6. Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation 7. Able to provide informed consent 8. Be willing to use a contraceptive method for a year after transplant Exclusion criteria (recipients): 1. HIV positive 2. HCVAb or HCV RNA positive 3. Presence of behavioral risk factors for contracting HCV. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting. 4. Hepatitis B surface antigen positive 5. History of atrial fibrillation requiring the use of amiodarone over the past 12m 6. Receipt of prior organ transplant 7. Waitlisted for a multi-organ transplant 8. Pregnant women 9. Known allergy to sofosbuvir/velpatasvir 10. Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study Inclusion criteria (donors): 1. HCV antibody positive 2. HCV NAT negative or positive Exclusion criteria (donors): 1. Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT) 2. Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT) 3. Known ongoing therapy for HCV

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Conditions

The condition(s) this trial relates to.

chronic liver failure hepatitis C virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis C Liver transplant

Contacts and locations

Locations

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.