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

NCT ID: NCT04452578

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-10
• Study Completion Date: 2022-06-17

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Procedure: Heart Transplantation

Intervention Type: PROCEDURE

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.

Interventions

Procedure: Heart Transplantation

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Loma Linda University Transplant Institute

Loma Linda, California, United States

Countries

United States

Other Identifiers

5190371

Identifier Type: -

Identifier Source: org_study_id