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Maribavir for CMV Infection in Children and Adolescents After Transplant

This study is testing a medication called maribavir in children and teenagers (up to 17 years old) who have a cytomegalovirus (CMV) infection after receiving a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT). CMV is a common virus that can cause serious problems in people with weakened immune systems. The main goals are to understand how safe maribavir is, how well the body handles it (pharmacokinetics), and how effective it is at treating the infection. Researchers also want to find the best dose of maribavir. The study is planning to enroll 80 participants. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 80 participants. It aims to find the optimal dose of maribavir.
What's involved
Participants will receive maribavir for 8 weeks. They will need to visit their doctor during a 12-week follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 12-week follow-up period after the 8-week treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05319353

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

Recruiting
PHASE3Up to 17InterventionalTreatment
Takeda
~80 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Maribavir

At a glance

Recruiting sites
53 of 53 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Observed Plasma Concentration (Cmax) of Maribavir
Measured over Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
+8 more outcomes measured

Conditions

Cytomegalovirus (CMV)

Explore related trials

Cytomegaloviral InfectionCytomegaloviral Infection

NCT05319353

Where you'd take part

This study runs at 53 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

    Chicago, Illinoisstudy coordinator listed

    Recruiting

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

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

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

    Birmingham, West Midlands, United Kingdomstudy coordinator listed

    Recruiting

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

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

  • CHRU Nantes

    Nantes, Loire-Atlantique, Francestudy coordinator listed

    Recruiting

  • CHU de Grenoble Alpes - Hôpital Michallon

    La Tronche, Isère, Francestudy coordinator listed

    Recruiting

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, Ille-et-Vilaine, Francestudy coordinator listed

    Recruiting

  • Cincinnati Children's Hospital Medical Center - PIN

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · Takeda

Who to contact

Takeda Contact
[email protected]
+1-877-825-3327
Email the study team

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • Maximum Observed Plasma Concentration (Cmax) of MaribavirPre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

    Cmax of maribavir will be evaluated.

  • Time to Maximum Observed Concentration (Tmax) of MaribavirPre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

    Tmax of maribavir will be evaluated.

  • Minimum Plasma Concentration (Cmin) of MaribavirPre-dose; (0.5, 1.5, 3, 4, 6, and 8 hours post-dose) on Day 7 (Week 1); Pre-dose on Day 28 (Week 4); Pre-dose; (2 to 4 hours post-dose) on Day 56 (Week 8)

    Cmin of maribavir will be evaluated.

  • Area Under the Plasma Concentration-Time Curve Over the 1 Dosing Interval of 12 Hours at Steady State (AUC0-tau) of MaribavirPre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

    AUC0-tau of maribavir will be evaluated.

  • Half-Life (t1/2) of MaribavirPre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

    t1/2 of maribavir will be evaluated.

  • Terminal Elimination Rate Constant (lambdaz) of MaribavirPre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

    Lambdaz of maribavir will be evaluated.

  • Apparent Volume of Distribution (Vz/F) of MaribavirPre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

    Vz/F of maribavir will be evaluated.

  • Apparent Oral Clearance (CL/F) of MaribavirPre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

    CL/F of maribavir will be evaluated.

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From start of study drug administration up to follow-up (Week 20)

    An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily be considered related to investigational product. SAE is any untoward medical occurrence (whether considered related to investigational product or not) that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, or is an important medical event.