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New hope for young transplant patients: maribavir trial targets CMV

NCT ID NCT05319353

Disease control Sponsor: Takeda 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a drug called maribavir for children and teens who have a CMV infection after a stem cell or organ transplant. About 80 participants will take the drug for 8 weeks and be followed for 12 more weeks. The goal is to find the safest dose and see how well it controls the virus.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

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

Started

Nov 2023

Expected to finish

Jan 2027

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: * Parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participant, as age appropriate, before completing any study-related procedures. * Be a male or female child or adolescent \< 18 years of age at the time of consent. For participants in Cohort 3 only (0 to \<6 years) must have a gestational age of at least 39 weeks and a minimum weight of 5 kg. * Be a recipient of an SOT or an HSCT that is functioning at the time of screening. * Have a documented CMV infection which may be a first episode of post-transplant CMV viremia (primary or reactivation) or refractory to other anti-CMV treatments, with a CMV DNA screening value of \>= 1365 International Units per milliliter (IU/mL) in whole blood or \>= 455 IU/mL in plasma in 2 consecutive assessments separated by at least 1 day, as determined by local laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative nucleic acid amplification test (qNAAT) results. Quantitative assays must be standardized to the World Health Organization (WHO) CMV International Standard. Both samples must be taken within 14 days of first dose of study drug, with the second sample obtained within 5 days prior to first dose of study drug. The same laboratory and same sample type (whole blood or plasma) must be used for both assessments. If documented and verified values are available in medical history that fulfill this criterion entirely, they may be used instead. * Have all the following results as part of screening laboratory assessments: * Absolute neutrophil count \>= 500 per cubic millimeter (/mm\^3) (0.5 × 10\^9 per liter \[/L\]) * Platelet count \>= 15,000/mm\^3 (15 × 10\^9/L) * Hemoglobin \>= 8 grams per deciliter (g/dL) (\>=80 grams per liter \[g/L\]). * Have an estimated glomerular filtration rate (creatinine-based Bedside Schwartz equation) \>= 30 milliliters per minute (mL/min) /1.73 meter square (m\^2). * Be a female of nonchildbearing potential. If a female of childbearing potential, have a negative serum human chorionic gonadotropin (hCG) or beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating females who are sexually active must agree to comply with the applicable contraceptive requirements of this protocol during the study treatment administration period and for 90 days after the last dose of study treatment. * Have life expectancy of \>= 8 weeks. * Be willing and have an understanding and ability to fully comply with the study procedures and restrictions defined in the protocol. For younger children, the parent/both parents or LAR must meet this criterion. * Participants must have a confirmed negative human immunodeficiency virus (HIV) test result within 3 months of first dose of study drug or, if unavailable, be tested by a local laboratory during the screening period. Exclusion Criteria: * Have CMV tissue invasive disease involving the central nervous system (CNS) or retina as assessed by the investigator at the time of screening. * Have uncontrolled other type of infection as assessed by the investigator on the date of enrollment. * Have a history of clinically relevant alcohol or drug abuse that may interfere with treatment compliance or assessments with the protocol as determined by the investigator. * Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate when study treatment is initiated, or anticipated to require one of these agents during the 8-week treatment period. * Have a known hypersensitivity to maribavir or to any excipients. * Have severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of study treatment or a GI absorption abnormality that would preclude administration of oral medication. * Require mechanical ventilation or vasopressors for hemodynamic support at baseline (Visit 2/Day 1/Week 0). * Be pregnant (or expecting to conceive) or nursing. * Have previously completed, discontinued, or have been withdrawn from this study. * Have received any investigational agent or device within 30 days before initiation of study treatment (includes CMV specific T-cells) or plan to receive an investigational agent or device during the study. Previously approved agents under investigation for additional indications are not exclusionary. * Have previously received maribavir or CMV vaccine at any time. * Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the study treatment, or compromise the safety or well-being of the participant. * Have severe liver disease (Child-Pugh score of \>= 10). * Have serum aspartate aminotransferase greater than (\>) 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase \> 5 times ULN at screening, or total bilirubin \>= 3.0 times ULN at screening (except for documented Gilbert's syndrome), as analyzed by local laboratory. * Have positive results for HIV. * Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which HSCT or SOT was performed), as determined by the investigator, are not to be enrolled. * Be undergoing treatment for acute or chronic hepatitis B or hepatitis C. * Requiring ongoing treatment with or an anticipated need for treatment with a strong cytochrome P450 3A (CYP3A) inducer. * Have a low body weight where total blood volume (TBV) required during study participation will exceed 1 percent (%) TBV per study visit or 3% TBV over a 4-week period.

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection

As listed by the trial registrant

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

Cytomegalovirus (CMV)

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

    53 sites in 11 countries. 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 and Robert H Lurie Childrens Hospital of Chicago - PIN

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Beijing Children's Hospital, Capital Medical University - PIN

    RECRUITING

    Beijing, Beijing Municipality, 100045, China

  • Birmingham Women's and Children's NHS Foundation Trust

    RECRUITING

    Birmingham, West Midlands, B4 6NH, United Kingdom

  • CHRU Nantes

    RECRUITING

    Nantes, Loire-Atlantique, 44000, France

  • CHU de Grenoble Alpes - Hôpital Michallon

    RECRUITING

    La Tronche, Isère, 38700, France

  • CHU de Rennes - Hôpital Pontchaillou

    RECRUITING

    Rennes, Ille-et-Vilaine, 35200, France

  • Capital Center For Children's Healthy, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100020, China

  • Cincinnati Children's Hospital Medical Center - PIN

    RECRUITING

    Cincinnati, Ohio, 45229-3026, United States

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

  • Cook Children's Health Care System

    RECRUITING

    Fort Worth, Texas, 76104-2733, United States

  • Great Ormond Street Hospital

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Hadassah Medical Center- Ein Kerem - PPDS

    RECRUITING

    Petah Tikva, 4920235, Israel

  • Hopital Necker

    RECRUITING

    Paris, 75015, France

  • Hospital Do Rim E Hipertensão

    RECRUITING

    São Paulo, 04038-002, Brazil

  • Hospital Infantil Universitario Niño Jesus - PIN

    RECRUITING

    Madrid, 28009, Spain

  • Hospital Regional Universitario de Malaga - Hospital Materno-Infantil

    RECRUITING

    Málaga, Málaga, 29011, Spain

  • Hospital Sant Joan de Deu - PIN

    RECRUITING

    Espluges de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitario La Paz - PPDS

    RECRUITING

    Horcajo de la Sierra, Madrid, 28755, Spain

  • Hospital Universitario Vall d´Hebron- PPDS

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 05403-000, Brazil

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hyogo Prefectural Kobe Children's Hospital

    RECRUITING

    Chiba, 650-0047, Japan

  • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

    RECRUITING

    Brussels, Brussels Capital, 1020, Belgium

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Johns Hopkins All Children's Hospital - Main - PIN

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • King's College Hospital

    RECRUITING

    London, Lambeth, SE5 9RS, United Kingdom

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Minderoo Children's Comprehensive Cancer Centre

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • National Center for Child Health and Development

    RECRUITING

    Setagaya-Ku, Tokyo, 157-8535, Japan

  • Nemours Children's Health - Wilmington - PIN

    RECRUITING

    Wilmington, Delaware, 19803-3607, United States

  • Nottingham University Hospitals NHS Trust

    RECRUITING

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Osaka Women's and Children's Hospital

    RECRUITING

    Izumi-Shi, Ôsaka, 594-1101, Japan

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Queensland Children's Hospital

    RECRUITING

    Woollangabba, Queensland, 4101, Australia

  • Rambam Health Care Campus - PPDS

    RECRUITING

    Haifa, 31096, Israel

  • Royal Children's Hospital Melbourne - PIN

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Royal Manchester Children's Hospital - PIN

    RECRUITING

    Manchester, Lancashire, M13 9WL, United Kingdom

  • Saitama Prefectural Children's Medical Center

    RECRUITING

    Saitama-Shi Chuo-Ku, Saitama, 330-8777, Japan

  • Shanghai Children's Medical Center - Zhangjiang Campus

    RECRUITING

    Shanghai, Shanghai Municipality, 200127, China

  • Shenzhen Children's Hospital

    RECRUITING

    Shenzhen, Guangdong, 518038, China

  • Shizuoka Children's Hospital

    RECRUITING

    Aoi-ku, Shizuoka, 420-8660, Japan

  • Tel Aviv Sourasky Medical Center Ichilov - PPDS

    RECRUITING

    Tel Aviv, Tel Aviv, 64239, Israel

  • Texas Children's Hospital - Wallace Tower - PIN

    RECRUITING

    Houston, Texas, 77030, United States

  • The Chaim Sheba Medical Center - PPDS

    RECRUITING

    Ramat Gan, Tel Aviv, 52394, Israel

  • The First Affiliated Hospital, Sun Yat-sen University - Main

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • UZ Gent

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101

    RECRUITING

    Jena, Thuringia, 07745, Germany

  • University of Nebraska Medical Center -985400 Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68114-4113, United States

  • University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd

    RECRUITING

    Houston, Texas, 77030-4000, United States

  • Universitätsklinikum Hamburg Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Münster

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitätsklinikum Würzburg

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.