A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors

This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatitis C; Heart Transplant Infection; Kidney Transplant; Complications
• Intervention / Treatment: Drug: Mavyret

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection
• Willing to accept and consent for accepting hepatitis C positive graft

Exclusion criteria:

• Existing chronic liver disease (liver cirrhosis)
• Concomitant infection with HIV or Chronic hepatitis B
• Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
• Pregnancy (Pregnant patients do not undergo solid organ transplants)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Pre-emptive Treatment Arm; Single arm study were all recipients of HCV viremic organs will receive combination therapy.	Drug: Mavyret; Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients; Other Names: Zetia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs	The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.	3 months
Graft and patient survival	Study will assess the overall 1 year patient and graft survival.	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bashar A Aqel, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azetidines; Azetines; Ezetimibe; glecaprevir and pibrentasvir
• Other Study ID Numbers: 20-001964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No