Liver TransplantPhase 2NCT03819322
The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
A Phase 2 study testing sofosbuvir/velpatasvir in people with Liver Transplant and Hepatitis C, run by Fernanda P Silveira, MD, MS at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant, Hepatitis C
- What is being tested?
- sofosbuvir/velpatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 17 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage liver disease listed for liver transplantation at UPMC.
- Age ≥ 18
- No available living liver donor
- Listed for an isolated liver transplant at UPMC
- Have panel reactive antibody level of <98%
- Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
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- Able to provide informed consent
- Be willing to use a contraceptive method for a year after transplant
- HCV antibody positive
- HCV NAT negative or positive
Who cannot join
- HIV positive
- HCVAb or HCV RNA positive
- 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.
- Hepatitis B surface antigen positive
- History of atrial fibrillation requiring the use of amiodarone over the past 12m
- Receipt of prior organ transplant
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- Waitlisted for a multi-organ transplant
- Pregnant women
- Known allergy to sofosbuvir/velpatasvir
- 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
- Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)
- Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT)
- Known ongoing therapy for HCV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transplantation of Livers of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa®)
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).
Read the detailed description
This is a prospective, single center, pilot, open-label study of transplantation of livers of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipients of a liver from HCVAb+/NAT- donors will be in arm 1 (the transmission-triggered arm) of the study. In this arm, the study will monitor transmission of HCV by measuring HCV RNA in liver transplant recipients. If HCV RNA is detected, indicating transmission of HCV, recipients will be treated with sofosbuvir/velpatasvir (Epclusa®) for 12 weeks. Virological response will be assessed at 4 weeks, end of treatment and 12 weeks after completion of therapy.
Recipients of a liver from HCVAb+/NAT+ donors will be in arm 2 (the prophylaxis arm) of the study. In this arm, patients will be started on a 12-week course of sofosbuvir/velpatasvir (Epclusa®) immediately post-operatively and will undergo close monitoring of HCV RNA for evidence of transmission.
To be eligible for the study, subjects need to be listed for liver transplantation, be not infected with HCV, HBV or HIV, and sign informed consent.
- Conditions
- Liver Transplant, Hepatitis C
- Being tested
- sofosbuvir/velpatasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir/velpatasvirDrug
Also called Epclusa
12 week, oral, fixed dose
| Study group | Role | What they receive |
|---|---|---|
| HCV seropositive non-viremic (HCV Ab+/NAT-) donor | Experimental | 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). Receives: Drug: sofosbuvir/velpatasvir |
| HCV seropositive viremic (HCV Ab+/NAT+) donor | Experimental | 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). Receives: Drug: sofosbuvir/velpatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Due to Sofosbuvir/Velpatasvir (Epclusa)
Adverse events due to sofosbuvir/velpatasvir (Epclusa)
Measured: 5 years
HCV Free at 1 Year Following Transplantation
Measured: 1 year
Secondary outcomes (5)
Transmission Rate of HCV From HCVAb+/NAT- Donors to HCVAb- Recipients
Measured: 5 years
Incidence of Allograft Rejection at 5 Years
Measured: 5 years
Incidence of Graft Loss at 5 Years
Measured: 5 years
All-cause Mortality at 5 Years
Measured: 5 years
Waitlist Time After Enrollment
In days
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start15 Aug 2019
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernanda P Silveira, MD, MS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Sponsor-investigator, Fernanda P Silveira, MD, MS, University of Pittsburgh
- Investigators
- Fernanda Silviera, MD, Study director, University of PittsburghNaudia Jonassaint, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819322
- Sponsor's protocol ID
- STUDY19100082
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2019
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual patient data outside of our investigative team. Aggregate data will be shared in publications as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Livers of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa®)
- ClinicalTrials.gov ID
- NCT03819322
- Acronym / sponsor ID
- STUDY19100082
- Conditions
- Liver Transplant, Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fernanda P Silveira, MD, MSUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 30 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a prospective, single center, pilot, open-label study of transplantation of livers of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipients of a liver from HCVAb+/NAT- donors will be in arm 1 (the transmission-triggered arm) of the study. In this arm, the study will monitor transmission of HCV by measuring HCV RNA in liver transplant recipients. If HCV RNA is detected, indicating transmission of HCV, recipients will be treated with sofosbuvir/velpatasvir (Epclusa®) for 12 weeks. Virological response will be assessed at 4 weeks, end of treatment and 12 weeks after completion of therapy.
Recipients of a liver from HCVAb+/NAT+ donors will be in arm 2 (the prophylaxis arm) of the study. In this arm, patients will be started on a 12-week course of sofosbuvir/velpatasvir (Epclusa®) immediately post-operatively and will undergo close monitoring of HCV RNA for evidence of transmission.
To be eligible for the study, subjects need to be listed for liver transplantation, be not infected with HCV, HBV or HIV, and sign informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV seropositive non-viremic (HCV Ab+/NAT-) donor | Experimental | Drug: sofosbuvir/velpatasvirLiver 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). |
| HCV seropositive viremic (HCV Ab+/NAT+) donor | Experimental | Drug: sofosbuvir/velpatasvirPost-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with end-stage liver disease listed for liver transplantation at UPMC.
- Age ≥ 18
- No available living liver donor
- Listed for an isolated liver transplant at UPMC
- Have panel reactive antibody level of <98%
Key exclusion criteria (13 listed)
- HIV positive
- HCVAb or HCV RNA positive
- 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.
- Hepatitis B surface antigen positive
- History of atrial fibrillation requiring the use of amiodarone over the past 12m
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sofosbuvir/velpatasvirAlso: Epclusa12 week, oral, fixed dose | Drug | HCV seropositive non-viremic (HCV Ab+/NAT-) donor, HCV seropositive viremic (HCV Ab+/NAT+) donor |
Primary outcome
Adverse Events Due to Sofosbuvir/Velpatasvir (Epclusa)
Time frame: 5 years
Adverse events due to sofosbuvir/velpatasvir (Epclusa)
HCV Free at 1 Year Following Transplantation
Time frame: 1 year
5 secondary outcomes
Transmission Rate of HCV From HCVAb+/NAT- Donors to HCVAb- Recipients
Time frame: 5 years
Incidence of Allograft Rejection at 5 Years
Time frame: 5 years
Incidence of Graft Loss at 5 Years
Time frame: 5 years
All-cause Mortality at 5 Years
Time frame: 5 years
Waitlist Time After Enrollment
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We do not plan to share individual patient data outside of our investigative team. Aggregate data will be shared in publications as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda Silviera, MD study director
University of Pittsburgh
Naudia Jonassaint, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sofosbuvir/velpatasvir in people with Liver Transplant and Hepatitis C, run by Fernanda P Silveira, MD, MS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events Due to Sofosbuvir/Velpatasvir (Epclusa) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.