Back to resultsHepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Procedure: Heart Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring HCV
Eligibility 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
Sites / Locations
- Loma Linda University Transplant Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Recipient of HCV positive heart graft
Arm Description
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.
Outcomes
Primary Outcome Measures
Patient Survival Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04452578
Brief Title
Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients
Official Title
Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
June 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
HCV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Recipient of HCV positive heart graft
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Procedure: Heart Transplantation
Intervention Description
A HCV negative or previously successfully treated recipient who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols.
Primary Outcome Measure Information:
Title
Patient Survival Rate
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Loma Linda University Transplant Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients
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