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

May 23, 2022 updated by: Saima Aslam, University of California, San Diego

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Drug: glecaprevir/pibrentasvir (GLE/PIB)
The study intervention consists of a single daily dose of GLE/PIB 100/40 mg (one dose consists of 3 tablets) administered orally; or crushed and administered via a feeding tube if participant is unable to swallow by mouth, for example in the immediate post-operative period. First dose will be administered in the pre-operative period within 4 hours of surgery followed by once daily doses for 7 days total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with Sustained Virological Response
Time Frame: 91 days
The primary outcome is the percentage of patients sustained virological response (SVR) at day 91 after completion of a 7-day course of GLE/PIB.
91 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with treatment-related Serious Adverse Events
Time Frame: 91 days
Safety and tolerability of the 7-day GLR/PIB course. Safety and tolerability will be assessed by documenting Serious Adverse Events (based on NIH criteria) for the duration of the study. Safety assessments will occur through review of the medical record of the patient, review of laboratory parameters and open-ended questions at the in-person assessments.
91 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2021

Primary Completion (Actual)

April 21, 2022

Study Completion (Actual)

April 21, 2022

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project #200895

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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