Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients

Launched by JOHNS HOPKINS UNIVERSITY · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to start treatment for Hepatitis C Virus (HCV) in patients receiving kidney transplants from donors who have HCV. The study will involve two groups: one group will begin HCV medication before the transplant and take it for just 2 weeks, while the other group will start the medication after the transplant and take it for a longer period of 12 weeks. The goal is to determine which approach is more effective for preventing HCV infection in kidney transplant recipients who do not currently have the virus.

To be eligible for this trial, participants must be at least 18 years old, meet the standard criteria for kidney transplantation, and be able to give informed consent. However, those with active HCV infection, certain liver conditions, or other significant health issues may not qualify. Participants can expect close monitoring during the trial and to receive either short or longer-term medication based on their group assignment. This study is currently recruiting participants, and it aims to improve treatment strategies for patients receiving kidney transplants from HCV-positive donors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant meets the standard criteria for KT at local center.
• • Participant is able to understand and provide informed consent.
• • Participant is ≥ 18 years old.
• Exclusion Criteria:
• • Participant has active HCV infection (detectable HCV RNA) at time of screening.
• • Participant has a Fibrosis-4 (FIB-4) score ≥ 3.25 at time of screening, or a history of cirrhosis or advanced liver fibrosis.
• • Participant's aspartate aminotransferase (AST) or ALT \> 2.5 times the upper limit of normal (ULN), within 60 days of screen.
• • Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.
• • Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.
• • Past or current medical problems, which may pose additional risks from participation in the study, interfere with the participant's ability to comply with study, or impact the quality of the data obtained from the study.
• • Participant is pregnant or breastfeeding.

Trial Officials