RECRUITING

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

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Conditions

HCV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial

Quick Facts

Study Start:2023-04-19
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05653232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant meets the standard criteria for KT at local center.
  2. * Participant is able to understand and provide informed consent.
  3. * Participant is ≥ 18 years old.
  1. * Participant has active HCV infection (detectable HCV RNA) at time of screening.
  2. * Participant has a Fibrosis-4 (FIB-4) score ≥ 3.25 at time of screening, or a history of cirrhosis or advanced liver fibrosis.
  3. * Participant's aspartate aminotransferase (AST) or ALT \> 2.5 times the upper limit of normal (ULN), within 60 days of screen.
  4. * Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.
  5. * Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.
  6. * 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.
  7. * Participant is pregnant or breastfeeding.

Contacts and Locations

Study Contact

Christine Durand, MD
CONTACT
410-955-5684
cdurand2@jhmi.edu

Principal Investigator

Christine Durand, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

University of California San Diego
La Jolla, California, 92037
United States
Johns Hopkins University
Baltimore, Maryland, 21205
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University of Utah Medical Center
Salt Lake City, Utah, 84132
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
University of Wisconsin, Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Christine Durand, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-19
Study Completion Date2027-03

Study Record Updates

Study Start Date2023-04-19
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • HCV