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

• Sponsor: Loma Linda University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04452578
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Procedure: Procedure: Heart Transplantation	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 10, 2020
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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 who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols.

Outcome Measures

Primary Outcome Measures

1. Patient Survival Rate [15 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Transplant Institute	Loma Linda	California	United States	92354

Sponsors and Collaborators

• Loma Linda University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT04452578
• Other Study ID Numbers: 5190371
• First Posted: Jun 30, 2020
• Last Update Posted: Nov 17, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Loma Linda University: HCV
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Nov 17, 2021