Actively Recruiting
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)
Led by Takeda · Updated on 2025-07-17
80
Participants Needed
47
Research Sites
166 weeks
Total Duration
On this page
Sponsors
T
Takeda
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legally authorized representative must provide informed consent and participant assent as appropriate.
- Male or female child or adolescent under 18 years of age at consent.
- For children under 6 years, gestational age at least 39 weeks and minimum weight of 5 kg.
- Recipient of a functioning solid organ transplant or hematopoietic stem cell transplant.
- Documented CMV infection with specific viral load thresholds in blood or plasma confirmed twice within 14 days before first dose.
- Absolute neutrophil count ≥ 500/mm³.
- Platelet count ≥ 15,000/mm³.
- Hemoglobin ≥ 8 g/dL.
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m².
- Female of nonchildbearing potential or negative pregnancy test if of childbearing potential.
- Agree to contraceptive requirements during treatment and for 90 days after last dose if sexually active.
- Life expectancy of at least 8 weeks.
- Willing and able to comply with study procedures.
- Confirmed negative HIV test within 3 months or during screening.
You will not qualify if you...
- CMV tissue invasive disease involving central nervous system or retina.
- Uncontrolled infection other than CMV.
- History of alcohol or drug abuse interfering with compliance.
- Receiving or expected to require valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate during treatment.
- Known hypersensitivity to maribavir or its ingredients.
- Severe vomiting, diarrhea, or gastrointestinal illness preventing oral medication.
- Need for mechanical ventilation or vasopressors at baseline.
- Pregnant or nursing.
- Prior participation or withdrawal from this study.
- Use of investigational agents or devices within 30 days before treatment.
- Previous maribavir or CMV vaccine use.
- Significant medical or surgical conditions affecting safety or study results.
- Severe liver disease or elevated liver enzymes.
- Positive HIV test.
- Active malignancy except nonmelanoma skin cancer.
- Undergoing treatment for hepatitis B or C.
- Need for strong CYP3A inducer treatment.
- Low body weight causing excessive blood volume needed for study tests.
AI-Screening
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Trial Site Locations
Total: 47 locations
1
University of Nebraska Medical Center -985400 Nebraska Medical Center
Omaha, Nebraska, United States, 68114-4113
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States, 45229-3026
Actively Recruiting
3
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104-2733
Actively Recruiting
4
University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd
Houston, Texas, United States, 77030-4000
Actively Recruiting
5
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
6
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
7
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia, 3052
Actively Recruiting
8
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
9
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Brussels Capital, Belgium, 1020
Actively Recruiting
10
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
Actively Recruiting
11
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
12
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
13
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
14
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
Actively Recruiting
15
Hospital Do Rim E Hipertensão
São Paulo, Brazil, 04038-002
Actively Recruiting
16
Children's Hospital Capital Institute of Pediatrics
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
17
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
18
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
19
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
20
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France, 35200
Actively Recruiting
21
CHU de Grenoble Alpes - Hôpital Michallon
La Tronche, Isère, France, 38700
Actively Recruiting
22
CHRU Nantes
Nantes, Loire-Atlantique, France, 44000
Actively Recruiting
23
Hopital Necker
Paris, France, 75015
Actively Recruiting
24
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
25
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
26
Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
Jena, Thuringia, Germany, 07745
Actively Recruiting
27
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
28
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
29
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, Israel, 52394
Actively Recruiting
30
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Tel Aviv, Israel, 64239
Actively Recruiting
31
Rambam Health Care Campus - PPDS
Haifa, Israel, 31096
Actively Recruiting
32
Hadassah Medical Center- Ein Kerem - PPDS
Petah Tikva, Israel, 4920235
Actively Recruiting
33
National Center for Child Health and Development
Nagoya, Aiti, Japan, 453-0046
Actively Recruiting
34
Saitama Children's Medical Center
Isehara-Shi, Kanagawa, Japan, 259-1143
Actively Recruiting
35
Shizuoka Children's Hospital
Aoi-ku, Shizuoka, Japan, 420-8660
Actively Recruiting
36
Hyogo Prefectural Kobe Children's Hospital
Chiba, Japan, 650-0047
Actively Recruiting
37
Osaka Women's and Children's Hospital
Izumi-Shi, Ôsaka, Japan, 594-1101
Actively Recruiting
38
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
39
Hospital Universitario La Paz - PPDS
Horcajo de la Sierra, Madrid, Spain, 28755
Actively Recruiting
40
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Málaga, Málaga, Spain, 29011
Actively Recruiting
41
Hospital Universitario Vall d´Hebron- PPDS
Barcelona, Spain, 08035
Actively Recruiting
42
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, Spain, 28009
Actively Recruiting
43
King's College Hospital
London, Lambeth, United Kingdom, SE5 9RS
Actively Recruiting
44
Royal Manchester Children's Hospital - PIN
Manchester, Lancashire, United Kingdom, M13 9WL
Actively Recruiting
45
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Actively Recruiting
46
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B4 6NH
Actively Recruiting
47
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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