Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego

Criteria

Inclusion Criteria:

• adults aged 18 years or greater

• participants actively listed for heart, lung and/or kidney transplant

• participants have already consented to receive HCV-viremic organs as part of the institution's clinical practice protocol (involves education and informed consent), and are able to sign informed consent for this research study.

Exclusion Criteria:

• participants who have a prior history of HCV infection regardless of treatment status, pre-existing human immunodeficiency virus (HIV) or hepatitis B virus (HBV) infection

• participants who are not able to sign informed consent for this research study

• participants who have not agreed to accept HCV+ organs as part of the UCSD clinical practice protocol

• participants who are listed for a liver transplant (either as a single organ or combined organ transplant).