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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 : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief 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®).

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Epclusa Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 : March 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
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.
Drug: Epclusa
If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 1-year post-transplant survival [ Time Frame: 1 year ]
    To evaluate the number of patients who survive 1-year post-transplant.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and capable of providing written informed consent
  2. Age ≥ 18 years
  3. Listed for isolated orthotopic heart transplant
  4. 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)

Exclusion Criteria:

  1. Listed for combined organ transplant
  2. Any of the following liver disease states, including:

    1. History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
    2. Hepatitis B surface Ag positive or detectable hepatitis B DNA,
    3. Cirrhosis, as indicated by liver biopsy,
    4. 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,
  3. History of prior solid organ transplant
  4. Pregnant individuals
  5. History of HIV infection
  6. 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
  7. Ongoing chronic amiodarone use (must be off regularly scheduled amiodarone a minimum of 28 days prior to enrollment), If amiodarone was acutely delivered, within 28 days of enrollment with a maximal dose of 600 mg within 48 hour period, subject will not be excluded.
  8. Patients who have undergone or who will undergo immune desensitization therapy
  9. Prospective-positive cross-match or predicted positive cross-match
  10. Patients unwilling to notify their sexual partner(s) of participation in this trial

Information from the National Library of Medicine

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


Contacts
Contact: Katalin Martits-Chalangari, MD 214-820-1722 Katalin.MartitsChalagari@BSWHealth.org

Locations
United States, California
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Dalia Galvan Tavera    310-248-7129    Dalia.GalvanTavera@csmns.org   
Principal Investigator: Evan Kransdorf, MD         
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Jennifer Wilson    919-668-8222    J.wilson@duke.edu   
Principal Investigator: Chet Patel, MD         
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Katalin Martits-Chalangari, MD    214-820-1722    KATALIN.MARTITSCHALANGARI@BSWHealth.org   
Principal Investigator: Robert Gottlieb, MD         
Sponsors and Collaborators
Baylor Research Institute
Investigators
Study Chair: Shelley Hall, MD, FACC, FHFSA Baylor Health Care System

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03383419     History of Changes
Other Study ID Numbers: Pending
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Baylor Research Institute:
Heart Failure, Heart Transplant

Additional relevant MeSH terms:
Heart Failure
Hepatitis C
Heart Diseases
Cardiovascular Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Antiviral Agents
Sofosbuvir-velpatasvir drug combination
Anti-Infective Agents