Recruiting

Direct-acting Antivirals

Sponsor:

Johns Hopkins University

Code:

NCT05653232

Conditions

HCV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prophylaxis (P2W)

Transmit and Treat (T&T)

Study Details

Brief summary:

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.

Conditions

HCV

Study ID

NCT05653232

Start date

Apr 19, 2023

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prophylaxis (P2W)

Prophylaxis is one dose of sofosbuvir/velpatasvir (SOF/VEL) pre-HCV D+/R- kidney transplant (KT), continued for 2 weeks.

experimental: Transmit and Treat (T&T)

T\&T is study-supplied SOF/VEL for 12 weeks starting on post-HCV D+/R- kidney transplant day participant's insurance approves standard of care DAAs, or post-KT day 14, whichever comes first.

Interventions

Prophylaxis (P2W)

For participants enrolled in P2W arm, the initial dose of SOF/VEL will be administered to the recipient when called to the operating room for transplant (typically 1-3 hours prior to the start of surgery). Post-transplant, SOF/VEL will be continued daily for 13 days post-KT (a total of 14 doses administered).

Transmit and Treat (T&T)

For participants enrolled in T\&T arm, SOF/VEL will begin between post-KT day 0 and post-KT day 14. Participants will be clinically-prescribed DAAs once viremia is detected, and participant's insurance will be petitioned to obtain treatment as soon as possible. If insurance-provided DAAs are approved before post-KT day 14, participant will begin 12 weeks of study-provided SOF/VEL on date of insurance-provided DAAs approval. If insurance-provided DAAs are not approved by post-KT day 14, study-provided SOF/VEL will begin on post-KT day 14 and continue for 12 weeks.

Primary outcome measure

  • Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse [ Time Frame: Within 26 weeks of transplant ]
  • Number of participants with liver injury [ Time Frame: The first 28 days post-transplant ]

Central Contacts and Locations

Central contacts

Christine Durand, MD

410-955-5684cdurand2@jhmi.edu

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Saima Aslam, MD

saslam@ucsd.edu

Principal Investigator:

Saima Aslam, MD

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92408

Contacts

Mina Rakoski, MD

mrakoski@llu.edu

Principal Investigator:

Mina Rakoski, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Christine Durand, MD

410-955-5684cdurand2@jhmi.edu

Principal Investigator:

Christine Durand, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Aprajita Mattoo, MD

Aprajita.Matoo@nyulangone.org

Principal Investigator:

Aprajita Mattoo, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Susan Lerner, MD

Susan.Lerner@mountsinai.org

Principal Investigator:

Susan Lerner, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Fernanda Silveira, MD

silvfd@upmc.edu

Principal Investigator:

Fernanda Silveira, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Gaurav Gupta, MD

gaurav.gupta@vcuhealth.org

Principal Investigator:

Gaurav Gupta, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-04.