Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients (TROJAN-C)
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|ClinicalTrials.gov Identifier: NCT03383419|
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Epclusa||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients|
|Actual Study Start Date :||March 20, 2018|
|Estimated Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||February 28, 2021|
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.
If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course.
- 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-year post-transplant survival [ Time Frame: 1 year ]To evaluate the number of patients who survive 1-year post-transplant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383419
|Contact: Victoria Flores, MBA, ACRP-CP||214-820-9888||Victoria.Flores@BSWHealth.org|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Sean Sana 310-248-7129 Sean.Sana@cshs.org|
|Principal Investigator: Evan Kransdorf, MD|
|United States, North Carolina|
|Duke University Medical Center||Active, not recruiting|
|Durham, North Carolina, United States, 27705|
|United States, Texas|
|Baylor University Medical Center||Recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Amanda Doss 214-865-2419 Amanda.Doss@BSWHealth.org|
|Principal Investigator: Robert Gottlieb, MD|
|Study Chair:||Shelley Hall, MD, FACC, FHFSA||Baylor Health Care System|