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Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452578
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Dmirty Abramov, Loma Linda University

Brief Summary:
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Procedure: Heart Transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Recipient of HCV positive heart graft
A single center, open-label, pilot study examining 10 adult HCV negative heart transplant subjects who will receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after heart transplantation.
Procedure: Procedure: Heart Transplantation
A HCV negative or previously successfully treated recipient with a HCV positive graft.




Primary Outcome Measures :
  1. Patient Survival Rate [ Time Frame: 15 months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female
  • Age 18 and older
  • Active on the transplant list
  • Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
  • HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
  • Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject
  • Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team

Exclusion Criteria:

  • Participants co-infected with HIV
  • Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
  • Known allergies or hypersensitivity to DAA or ribavarin
  • Pregnancy and/or actively breastfeeding

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): NCT04452578


Contacts
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Contact: Dmitry Abramov, MD 9095588184 dabramov@llu.edu

Locations
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United States, California
Loma Linda University Transplant Institute Recruiting
Loma Linda, California, United States, 92354
Contact: Dmitry Abramov, MD    909-558-8184    dabramov@llu.edu   
Sponsors and Collaborators
Loma Linda University
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Responsible Party: Dmirty Abramov, Assistant Professor, Loma Linda Medical Center, Loma Linda University
ClinicalTrials.gov Identifier: NCT04452578    
Other Study ID Numbers: 5190371
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dmirty Abramov, Loma Linda University:
HCV
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases