Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by Saima Aslam, MD

Description

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).

Official Title

Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor to HCVNegative Organ Transplant Recipient - Pilot Trial

Keywords

Hepatitis C Hepatitis C Virus Infection, Response to Therapy of Hepatitis A Hepatitis glecaprevir/pibrentasvir (GLE/PIB)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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).

Location

  • University of California San Diego
    San Diego California 92037 United States

Lead Scientist at UCSD

  • Saima Aslam, MD
    Associate Professor, Medicine. Authored (or co-authored) 49 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04596475
Phase
Phase 1/2
Study Type
Interventional
Last Updated