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New hope for young transplant patients: drug trial targets dangerous virus

NCT ID NCT07199465

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This study is testing the drug letermovir to prevent cytomegalovirus (CMV) infection in children and teens who have had a kidney transplant and weigh less than 40 kg. About 40 participants will receive the drug to see how it moves through their bodies and if it is safe. The goal is to find a better way to protect these young patients from a common virus that can cause serious problems after transplant.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

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

Started

Mar 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

Up to 17 years

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: The main inclusion criteria include but are not limited to the following: * Is a recipient of a primary or secondary allograft kidney * Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local standard of care * Has stable kidney function posttransplant * Has undetectable CMV deoxyribonucleic acid (DNA) from a plasma or whole blood sample collected within 14 days prior to enrollment * Must be able to take (as assessed by the investigator) letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube (oral pellets only) * Does not have a condition that may interfere with the absorption of oral medication (e.g., vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment (Day 1) until the intensive pharmacokinetics (IPK) sampling is completed * Weighs ≥2.5 and \<40 kg at enrollment (Day 1) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has CMV disease or suspected CMV disease between screening and enrollment * Is on dialysis or plasmapheresis at the time of enrollment * Has evidence of CMV viremia at any time from screening until the time of enrollment * Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment * Is a multi-organ transplant recipient (e.g., kidney-pancreas) * Has any uncontrolled infection on the day of enrollment * Requires mechanical ventilation, or is hemodynamically unstable, at the time of enrollment * Has received or is receiving protocol-specified prohibited medications

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection prevention target

As listed by the trial registrant

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

Cytomegalovirus prophylaxis

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Children's Healthcare of Atlanta-Center for Advanced Pediatrics ( Site 0020)

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado ( Site 0013)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles ( Site 0016)

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia (CHOP) ( Site 0003)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh - Department of Pediatrics ( Site 0011)

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Cincinnati Children's Hospital Medical Center ( Site 0002)

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Duke University-Pediatrics ( Site 0008)

    RECRUITING

    Durham, North Carolina, 27110, United States

  • Levine Children's Hospital ( Site 0022)

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Lucile Packard Children's Hospital ( Site 0001)

    RECRUITING

    Palo Alto, California, 94304, United States

  • M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007)

    RECRUITING

    Minneapolis, Minnesota, 55454, United States

  • Mayo Clinic - Rochester ( Site 0015)

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Montefiore Medical Center ( Site 0024)

    RECRUITING

    The Bronx, New York, 10467, United States

  • Morgan Stanley Children's Hospital ( Site 0018)

    RECRUITING

    New York, New York, 10032, United States

  • Texas Children's Hospital ( Site 0005)

    RECRUITING

    Houston, Texas, 77030, United States

  • UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF Medical Center at Mission Bay ( Site 0017)

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019)

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California Davis Health ( Site 0023)

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Miami School of Medicine ( Site 0021)

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan ( Site 0014)

    RECRUITING

    Ann Arbor, Michigan, 48109, United States