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
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2020
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedStudy Start
First participant enrolled
September 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedDecember 17, 2025
December 1, 2025
5.1 years
July 30, 2020
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Arm 1: Pre-emptive Treatment Arm
EXPERIMENTALSingle arm study were all recipients of HCV viremic organs will receive combination therapy.
Interventions
Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Arizona
Phoenix, Arizona, 85054, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bashar A Aqel
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 30, 2020
First Posted
August 11, 2020
Study Start
September 10, 2020
Primary Completion
November 1, 2025
Study Completion (Estimated)
November 1, 2026
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share