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

NCT04452578 | Completed DMC

• 1 other identifier: 5190371
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

HCV

Outcome Measures

Primary Outcomes (1)

• Patient Survival Rate

  15 months

Study Arms (1)

Experimental: Recipient of HCV positive heart graft

EXPERIMENTAL

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

Interventions

Procedure: Heart Transplantation 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.

Experimental: Recipient of HCV positive heart graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Transplant Institute

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: June 10, 2020
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)