Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Launched by SENTARA NORFOLK GENERAL HOSPITAL · Mar 21, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment approach for patients who are awaiting a heart transplant and may receive organs from donors who are infected with the hepatitis C virus (HCV). The study specifically looks at the safety and effectiveness of a combination therapy called glecaprevir/pibrentasivir, which is given to patients after their transplant to help protect them from HCV infection. By comparing patients who receive organs from HCV-positive donors to those who receive organs from HCV-negative donors, researchers aim to understand how well this treatment works in preventing or managing HCV infection in these patients.

To be eligible for the trial, participants must be at least 18 years old, on the transplant waiting list for a heart, and able to provide informed consent. Those with a history of serious liver disease or other specific health conditions, as well as pregnant individuals and those with HIV, cannot participate. If you join the study, you will receive the treatment after your transplant and will be closely monitored for any side effects or changes in your health. This research is important as it could improve outcomes for heart transplant recipients who might be at risk of contracting HCV from their donors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects must meet all of the inclusion criteria specified below in order to be eligible for participation in this study
• • 1. Willing and capable of providing written informed consent
• • 2. Age ≥18 years
• • 3. On UNOS list as a candidate for heart transplant
• Exclusion Criteria:
• • Subjects who meet any of the following exclusion criteria cannot be enrolled in this study.
• • 1. Individuals under 18 years of age
• • 2. History of advanced liver disease, including active hepatitis B or C, detectable hepatitis B surface Ag, hepatitis B DNA, HCV RNA, or cirrhosis
• • 3. Pregnant individuals
• • 4. HIV antibody positive