Skip to main content
OpenTrials
Completed

NCT Number: NCT04452578

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Transplant Institute

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient Survival Rate

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2020
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.