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

RecruitingNAAges 18 Years - anyAllJohns Hopkins University
NCT05653232 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+/R-) kidney transplants. Participants will be randomized into one of two groups: Arm 1 - Prophylaxis: This group will start the HCV medication before transplant and will take a shorter course of HCV medication for 2 weeks. Arm 2 - Transmit and Treat: This group will start the HCV medication after transplant and will take the full course (12 weeks) of HCV medication.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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 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.
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What it tests

  • Prophylaxis (P2W)
  • Transmit and Treat (T&T)
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Where

9 sites
University of California San Diego
La Jolla, United States
Loma Linda University Health
Loma Linda, United States
Johns Hopkins University
Baltimore, United States
NYU Langone Health
New York, United States
Icahn School of Medicine at Mount Sinai
New York, United States
University of Pittsburgh Medical Center
Pittsburgh, United States
University of Utah Medical Center
Salt Lake City, United States
Virginia Commonwealth University
Richmond, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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