Hepatitis CPhase 2NCT03222531
Expanding the Pool in Orthotopic Heart Transplantation
A Phase 2 study testing sofosbuvir/velpatasvir in people with Hepatitis C and Heart Transplant, run by Mary E. Keebler, MD at 1 site in United States.
Trial summary
This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart transplant waitlist. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Hepatitis C, Heart Transplant, Cardiac Transplant
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 2 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage heart failure
- Age ≥ 18 and <71 years
- Listed heart transplant at UPMC
- Have panel reactive antibody level of <98%
- No obvious contraindication to liver transplant
- 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
- Acceptable cardiac function for donation
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 liver cirrhosis
- Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months
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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
- Ongoing therapy with amiodarone for atrial or ventricular arrhythmia Prescribed use of Amiodarone
- 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: Expanding the Pool in Orthotopic Heart Transplantation: The Use of Hepatitis C Positive Donor Hearts in Hepatitis C Negative Recipients
This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart 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 hearts of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipients of a heart from HCVAb+/NAT- donors is ARM 1 or the transmission-triggered arm of the study. In this arm, the study will monitor transmission of HCV by measuring HCV RNA in heart 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 heart from HCVAb+/NAT+ donors will be in ARM 2 or the prophylaxis arm of the study. In this arm, patients will be started on a 12-week course of sofosbuvir/velpatasvir (Epclusa®) on post-operative day 1 and will undergo close monitoring of HCV RNA for evidence of transmission as well as monitoring of adverse events from therapy.
- Conditions
- Hepatitis C, Heart Transplant, Cardiac Transplant
- 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
Drug: sofobuvir/velpatasvir
| Study group | Role | What they receive |
|---|---|---|
| HCV seropositive non-viremic (HCV Ab+/NAT-) donor | Experimental | HCV seropositive non-viremic (HCV Ab+/NAT-) donor hearts to HCV seronegative recipients.
Heart 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).
Intervention: Drug: sofosbuvir/velpatasvir Receives: Drug: sofosbuvir/velpatasvir |
| HCV seropositive viremic (HCV Ab+/NAT+) donor | Experimental | HCV seropositive viremic (HCV Ab+/NAT+) donor hearts to HCV seronegative recipients.
Starting post-operative day 1, heart 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).
Intervention: Drug: sofosbuvir/velpatasvir Receives: Drug: sofosbuvir/velpatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in patients in each experimental group
Measured: 5 years
HCV free at 1 year
Proportion of participants in each experimental group who are free of HCV 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
Measured: 5 years
Incidence of graft loss
Measured: 5 years
All-cause mortality
Measured: 5 years
Waitlist time after enrollment
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 posted19 Jul 2017
- Study start1 Aug 2017
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary E. Keebler, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary E. Keebler, MD, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222531
- Sponsor's protocol ID
- STUDY19030424
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2017
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Pool in Orthotopic Heart Transplantation: The Use of Hepatitis C Positive Donor Hearts in Hepatitis C Negative Recipients
- ClinicalTrials.gov ID
- NCT03222531
- Acronym / sponsor ID
- STUDY19030424
- Conditions
- Hepatitis C, Heart Transplant, Cardiac Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mary E. Keebler, MDUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
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 hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart 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 hearts of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipients of a heart from HCVAb+/NAT- donors is ARM 1 or the transmission-triggered arm of the study. In this arm, the study will monitor transmission of HCV by measuring HCV RNA in heart 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 heart from HCVAb+/NAT+ donors will be in ARM 2 or the prophylaxis arm of the study. In this arm, patients will be started on a 12-week course of sofosbuvir/velpatasvir (Epclusa®) on post-operative day 1 and will undergo close monitoring of HCV RNA for evidence of transmission as well as monitoring of adverse events from therapy.
Study design
- Primary purpose
- Other
- 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/velpatasvirHCV seropositive non-viremic (HCV Ab+/NAT-) donor hearts to HCV seronegative recipients. Heart 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). Intervention: Drug: sofosbuvir/velpatasvir |
| HCV seropositive viremic (HCV Ab+/NAT+) donor | Experimental | Drug: sofosbuvir/velpatasvirHCV seropositive viremic (HCV Ab+/NAT+) donor hearts to HCV seronegative recipients. Starting post-operative day 1, heart 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). Intervention: Drug: sofosbuvir/velpatasvir |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- End stage heart failure
- Age ≥ 18 and <71 years
- Listed heart transplant at UPMC
- Have panel reactive antibody level of <98%
- No obvious contraindication to liver transplant
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 liver cirrhosis
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: EpclusaDrug: sofobuvir/velpatasvir | Drug | HCV seropositive non-viremic (HCV Ab+/NAT-) donor, HCV seropositive viremic (HCV Ab+/NAT+) donor |
Primary outcome
Adverse Events
Time frame: 5 years
Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in patients in each experimental group
HCV free at 1 year
Time frame: 1 year
Proportion of participants in each experimental group who are free of HCV at 1 year following transplantation
5 secondary outcomes
Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients
Time frame: 5 years
Incidence of allograft rejection
Time frame: 5 years
Incidence of graft loss
Time frame: 5 years
All-cause mortality
Time frame: 5 years
Waitlist time after enrollment
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatitis C and Heart Transplant, run by Mary E. Keebler, MD 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 11 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 22 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (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 22 Jun 2026.