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

Phase 1

Completed

• Conditions: Hepatitis C; Hepatitis C Virus Infection, Response to Therapy of
• Interventions: Drug: glecaprevir/pibrentasvir (GLE/PIB)

• Registration Number: NCT04596475
• Lead Sponsor: University of California, San Diego

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Study Start: 2021-05-28
• Primary Completion: 2022-04-21
• Study Completion: 2022-04-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	glecaprevir/pibrentasvir (GLE/PIB)	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants with Sustained Virological Response	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with treatment-related Serious Adverse Events	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.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 San Diego, California, United States