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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Heart Transplant Infection Hepatitis Hepatitis, Viral, Human Infections Kidney Transplant; Complications Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mavyret

Drug

Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients

Other names: Zetia

Primary outcomes

Rate of prevention of HCV viremia in recipients of HCV viremic solid organs

Time frame: 3 months

The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.
Graft and patient survival

Time frame: 1 year

Study will assess the overall 1 year patient and graft survival.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2026
First posted: Aug 11, 2020
Registry last updated: Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting