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Can a short course of hepatitis c drugs before kidney transplant prevent infection?

NCT ID NCT05653232

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study looks at the best time to give hepatitis C medication to people without HCV who receive a kidney from an HCV-positive donor. One group starts the drug just before transplant and takes it for only 2 weeks; the other starts after transplant and takes it for 12 weeks. The goal is to see which approach prevents HCV infection more safely and effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sofosbuvir/Velpatasvir (SOF/VEL)
What this could lead to
If successful, this could show that starting HCV medication before transplant with a shorter course is safe and effective, potentially simplifying treatment and reducing costs.
What could go wrong
This is a relatively small, early-stage trial (120 participants) comparing two timing strategies, so results may not apply broadly. There is a risk of HCV transmission or liver injury despite prophylaxis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

hepatitis C virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HCV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Loma Linda University Health

    RECRUITING

    Loma Linda, California, 92408, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah Medical Center

    ACTIVE_NOT_RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Wisconsin, Madison

    TERMINATED

    Madison, Wisconsin, 53792, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

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