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)
NCT ID: NCT05319353
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2023-11-13
2027-01-18
Brief Summary
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The participants will be treated with maribavir for 8 weeks.
Participants need to visit their doctor during 12-week follow-up period.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1: Maribavir 400, 200 or 100 mg
Participants with greater than or equal to (\>=) 12 to less than (\<) 18 years of age will receive maribavir 400 milligrams (mg) (2\*200 mg tablets or powder for oral suspension) twice daily (BID) based on body weight \>= 25 kilogram (kg); or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).
Maribavir
Participants will receive maribavir.
Cohort 2: Maribavir 400, 200 or 100 mg
Participants with \>= 6 to \< 12 years of age will receive maribavir 400 mg (2\*200 mg tablets or powder for oral suspension) BID based on body weight \>= 25 kg; or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg orally for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).
Maribavir
Participants will receive maribavir.
Cohort 3: Maribavir 400, 200, 100 or 50 mg
Participants with 0 to \< 6 years of age will receive maribavir 400 mg (2\*200 mg tablets or powder for oral suspension) BID based on body weight \>= 25 kg; or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg; or 50 mg powder for oral suspension BID based on body weight 7 to \< 10 kg; or 50 mg powder for oral suspension once daily (QD) based on body weight 5 to \<7 kg for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).
Maribavir
Participants will receive maribavir.
Interventions
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Maribavir
Participants will receive maribavir.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
17 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of Nebraska Medical Center -985400 Nebraska Medical Center
Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd
Houston, Texas, United States
Sydney Children's Hospital
Randwick, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Brussels Capital, Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Do Rim E Hipertensão
São Paulo, , Brazil
Children's Hospital Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, Beijing Municipality, China
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality, China
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
CHU de Grenoble Alpes - Hôpital Michallon
La Tronche, Isère, France
CHRU Nantes
Nantes, Loire-Atlantique, France
Hopital Necker
Paris, , France
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
Jena, Thuringia, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus - PPDS
Haifa, , Israel
Hadassah Medical Center- Ein Kerem - PPDS
Petah Tikva, , Israel
National Center for Child Health and Development
Nagoya, Aiti, Japan
Saitama Children's Medical Center
Isehara-Shi, Kanagawa, Japan
Shizuoka Children's Hospital
Aoi-ku, Shizuoka, Japan
Hyogo Prefectural Kobe Children's Hospital
Chiba, , Japan
Osaka Women's and Children's Hospital
Izumi-Shi, Ôsaka, Japan
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain
Hospital Universitario La Paz - PPDS
Horcajo de la Sierra, Madrid, Spain
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Málaga, Málaga, Spain
Hospital Universitario Vall d´Hebron- PPDS
Barcelona, , Spain
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, , Spain
King's College Hospital
London, Lambeth, United Kingdom
Royal Manchester Children's Hospital - PIN
Manchester, Lancashire, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Fisher JE, Mulieri K, Finch E, Ericson JE. Use of Maribavir for Multidrug Resistant Cytomegaloviremia in a Pediatric Oncology Patient. J Pediatr Hematol Oncol. 2024 Apr 1;46(3):e244-e247. doi: 10.1097/MPH.0000000000002841. Epub 2024 Mar 1.
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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2021-004279-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2031230753
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-508988-73-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-620-2004
Identifier Type: -
Identifier Source: org_study_id
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