Heart FailurePhase 2TROJAN-CNCT03383419
Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
A Phase 2 study testing Epclusa in people with Heart Failure, run by Baylor Research Institute at 3 sites in United States.
Trial summary
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Epclusa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Mar 2018to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and capable of providing written informed consent
- Age ≥ 18 years
- Listed for isolated orthotopic heart transplant
- HCV seronegative (or, if HCV seropositive, then subject must be PCR negative on at least 2 draws consistent with a spontaneously cleared or fully-treated and cleared prior infection; in this case last anti-HCV antiviral dose must be ≥12 weeks ago and 2 negative titers ≥12 weeks after completion of the antiviral regimen)
Who cannot join
- Listed for combined organ transplant
- Any of the following liver disease states, including:
- History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
- Hepatitis B surface Ag positive(unless clinically determined to be previously negative and acutely positive due to vaccination with recombinant surface antigen) or detectable hepatitis B DNA,
- Cirrhosis, as indicated by liver biopsy,
- Portal hypertension as indicated by a hepatic venous pressure gradient > 5 mm Hg and/or the presence of esophageal varices e.) ALT and AST > 3x ULN unless adjudicated to be from a non-hepatic cardiac or skeletal muscle source,
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- History of prior solid organ transplant
- Pregnant individuals
- History of HIV infection
- History of severe renal disease currently requiring dialysis. Chronic kidney disease with creatinine clearance <30 ml/min/1.73m2 (by MDRD method) at screening or on last two consecutive measurements before acceptance of transplant organ offer
- Patients who have undergone or who will undergo immune desensitization therapy
- Prospective-positive cross-match or predicted positive cross-match
- Patients unwilling to notify their sexual partner(s) of participation in this trial
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Aayla Jamil, MBBS MPH, 214-820-1675, Aayla.Jamil@BSWHealth.org
Robert L Gottlieb, MD
- Active, not recruiting
Duke University Medical Center
Durham, North Carolina, 27705
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Sean Sana, 310-248-7129, Sean.Sana@cshs.org
Evan Kransdorf, MD
About this study
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
Read the detailed description
utilizing HCV-positive donors (defined as HCV-NAT positive) for heart transplantation in HCV-negative recipients treated with Epclusa®.
Subjects will be identified from the heart transplantation waitlist. Subjects who, according to the judgement of the Investigator, would have a net mortality benefit from cardiac transplantation irrespective of donor HCV status will be asked if they agree to receive a heart transplant from an HCV-positive donor. Subjects who sign consent and receive a heart transplant from an HCV-positive donor will be enrolled.
Consented subjects who do not demonstrate immunity to hepatitis B (manifest as negative qualitative or quantitative Hepatitis B surface Ab) will be encouraged to immediately begin a non-infectious recombinant hepatitis B surface antigen vaccination series, combined with, or in parallel to, an inactive hepatitis A vaccination at the treating clinician's discretion.
Enrolled recipients will be closely surveilled with serial HCV polymerase chain reaction (PCR) as inpatients during the immediate post-OHT hospitalization and subsequently as specified in the post-transplant period assessements. Donor serum will be collected at transplant harvest and will be sent by the transplant center for HCV NAT and genotyping. If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course. The study drug, Epclusa®, will be provided by Gilead Sciences, Inc. Study drug, Epclusa®, comes in bottles that contain 28 tablets each. Serologic data will also be collected. If an enrolled subject does not develop quantifiable viremia by week 12, they will be followed by standard of care surveillance, with additional standard of care surveillance per UNOS mandate for CDC-increased-risk donors and discontinued from study; additional subjects may be enrolled at the Principal Consortium Investigator's discretion to complete 20 Epclusa®-treated subjects according to the protocol.
- Conditions
- Heart Failure
- Being tested
- Epclusa
- Keywords
- Heart Failure, Heart Transplant
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpclusaDrug
If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Epclusa® will be started within 14 days of quantifiable viremia and continued for 12 weeks. Within 24 hours prior to first-dose of treatment, HCV genotype will be sent from transplant recipient. Receives: Drug: Epclusa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response after 12 weeks of treatment
To evaluate the number of patients with sustained virologic response (SVR) 12 weeks after discontinuation of therapy.
Measured: 12 weeks
Secondary outcomes (1)
1-year post-transplant survival
To evaluate the number of patients who survive 1-year post-transplant.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start20 Mar 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelley A Hall, MD, FACC, FHFSA, Study chair, Baylor University Medical Center/ Baylor Scott & White Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383419
- Sponsor's protocol ID
- 018-009
- Acronym
- TROJAN-C
- Status last verified
- Oct 2025
- First submitted
- 7 Dec 2017
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mozaffari E, Chandak A, Zhang Z, Liang S, Thrun M, Gottlieb RL, Kuritzkes DR, Sax PE, Wohl DA, Casciano R, Hodgkins P, Haubrich R. Remdesivir Treatment in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19): A Comparative Analysis of In-hospital All-cause Mortality in a Large Multicenter Observational Cohort. Clin Infect Dis. 2022 Aug 24;75(1):e450-e458. doi: 10.1093/cid/ciab875.
PubMed 34596223
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
- ClinicalTrials.gov ID
- NCT03383419
- Acronym / sponsor ID
- TROJAN-C / 018-009
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Heart Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Dec 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 phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
Detailed description
utilizing HCV-positive donors (defined as HCV-NAT positive) for heart transplantation in HCV-negative recipients treated with Epclusa®.
Subjects will be identified from the heart transplantation waitlist. Subjects who, according to the judgement of the Investigator, would have a net mortality benefit from cardiac transplantation irrespective of donor HCV status will be asked if they agree to receive a heart transplant from an HCV-positive donor. Subjects who sign consent and receive a heart transplant from an HCV-positive donor will be enrolled.
Consented subjects who do not demonstrate immunity to hepatitis B (manifest as negative qualitative or quantitative Hepatitis B surface Ab) will be encouraged to immediately begin a non-infectious recombinant hepatitis B surface antigen vaccination series, combined with, or in parallel to, an inactive hepatitis A vaccination at the treating clinician's discretion.
Enrolled recipients will be closely surveilled with serial HCV polymerase chain reaction (PCR) as inpatients during the immediate post-OHT hospitalization and subsequently as specified in the post-transplant period assessements. Donor serum will be collected at transplant harvest and will be sent by the transplant center for HCV NAT and genotyping. If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course. The study drug, Epclusa®, will be provided by Gilead Sciences, Inc. Study drug, Epclusa®, comes in bottles that contain 28 tablets each. Serologic data will also be collected. If an enrolled subject does not develop quantifiable viremia by week 12, they will be followed by standard of care surveillance, with additional standard of care surveillance per UNOS mandate for CDC-increased-risk donors and discontinued from study; additional subjects may be enrolled at the Principal Consortium Investigator's discretion to complete 20 Epclusa®-treated subjects according to the protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: EpclusaEpclusa® will be started within 14 days of quantifiable viremia and continued for 12 weeks. Within 24 hours prior to first-dose of treatment, HCV genotype will be sent from transplant recipient. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and capable of providing written informed consent
- Age ≥ 18 years
- Listed for isolated orthotopic heart transplant
- HCV seronegative (or, if HCV seropositive, then subject must be PCR negative on at least 2 draws consistent with a spontaneously cleared or fully-treated and cleared prior infection; in this case last anti-HCV antiviral dose must be ≥12 weeks ago and 2 negative titers ≥12 weeks after completion of the antiviral regimen)
Key exclusion criteria (13 listed)
- Listed for combined organ transplant
- Any of the following liver disease states, including:
- History of prior solid organ transplant
- Pregnant individuals
- History of HIV infection
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 |
|---|---|---|
| EpclusaIf and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course. | Drug | Treatment |
Primary outcome
Sustained virologic response after 12 weeks of treatment
Time frame: 12 weeks
To evaluate the number of patients with sustained virologic response (SVR) 12 weeks after discontinuation of therapy.
1 secondary outcome
1-year post-transplant survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 34596223Mozaffari E, Chandak A, Zhang Z, Liang S, Thrun M, Gottlieb RL, Kuritzkes DR, Sax PE, Wohl DA, Casciano R, Hodgkins P, Haubrich R. Remdesivir Treatment in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19): A Comparative Analysis of In-hospital All-cause Mortality in a Large Multicenter Observational Cohort. Clin Infect Dis. 2022 Aug 24;75(1):e450-e458. doi: 10.1093/cid/ciab875.
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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.
Shelley A Hall, MD, FACC, FHFSA study chair
Baylor University Medical Center/ Baylor Scott & White Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epclusa in people with Heart Failure, run by Baylor Research Institute at 3 sites 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 4 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aayla Jamil, MBBS MPH (214-820-1675, Aayla.Jamil@BSWHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virologic response after 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383419, which also lists 1 linked publication.
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 Jan 2026.