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

University of California San Diego

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatitis C

Hepatitis C Virus Infection, Response to Therapy of

Treatments

Drug: glecaprevir/pibrentasvir (GLE/PIB)

Study type

Interventional

Funder types

Other

Identifiers

NCT04596475

Project #200895

Details and patient eligibility

About

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).

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).