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

Heart Failure Clinical Trial

Official title:

Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452578
• Other study ID #: 5190371
• Status: Completed
• Phase: N/A
• Start date: June 10, 2020
• Est. completion date: June 17, 2022

Study information

• Verified date: November 2022
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University Transplant Institute	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Survival Rate		15 months