Use of Maribavir for Multidrug Resistant Cytomegaloviremia in a Pediatric Oncology Patient.
James E Fisher, Kevin Mulieri, Elizabeth Finch...
https://pubmed.ncbi.nlm.nih.gov/38447094Actively Recruiting
Phase 3
Age: 0 - 17Years
All Genders
ID05319353
A Phase 3 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for Treating CMV Infection in Children and Adolescents After Stem Cell or Organ Transplant
Led by Takeda · Updated on 2026-05-22
80
Participants Needed
53
Research Sites
N/A
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
Researchers are studying the safety, tolerability, and how the body processes maribavir in children and teenagers who have cytomegalovirus (CMV) infection after receiving a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT). This phase 3 trial aims to find the best dose of maribavir using either a 200 mg tablet or a powder for oral suspension formulation. The study focuses on these young patients who have documented CMV infection and evaluates maribavir's antiviral activity along with its pharmacokinetics. Participants receive maribavir for up to 8 weeks with doses adjusted based on age and body weight. For ages 12 to less than 18 years, dosing ranges from 100 mg to 400 mg twice daily depending on weight. Those aged 6 to less than 12 years follow a similar dosing scheme, and children younger than 6 years may receive doses from 50 mg once or twice daily up to 400 mg twice daily. The medication is taken orally as tablets or powder for oral suspension during the treatment period. During the study, participants will have multiple blood tests to measure maribavir levels at various time points, and adverse events will be monitored up to 20 weeks. There is a 12-week follow-up period after treatment ends, during which participants will visit their doctor to assess continued viral control and safety. Researchers will also evaluate the clearance of CMV viremia, recurrence rates, and resistance development, along with participant feedback on medication palatability.
CONDITIONS
Brief 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
Age: 0 - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Parent or legal representative must provide informed consent and participant assent as appropriate
- Male or female child or adolescent younger than 18 years at consent
- For children under 6 years, gestational age must be at least 39 weeks and weight at least 5 kg
- Recipient of a functioning hematopoietic stem cell transplant or solid organ transplant at screening
- Documented CMV infection with specific viral load thresholds confirmed by standardized lab tests
- Laboratory values within specified limits: neutrophil count ≥ 500/mm³, platelet count ≥ 15,000/mm³, hemoglobin ≥ 8 g/dL
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m²
- Female participants must be of nonchildbearing potential or have a negative pregnancy test if of childbearing potential
- Agree to comply with contraceptive requirements during treatment and 90 days after
- Life expectancy of at least 8 weeks
- Ability and willingness to comply with study procedures
- Confirmed negative HIV test within 3 months prior to dosing or during screening
You will not qualify if you...
- CMV tissue invasive disease involving central nervous system or retina
- Uncontrolled infections other than CMV at enrollment
- History of significant alcohol or drug abuse interfering with compliance
- Receiving or expected to require certain anti-CMV medications during treatment period
- Known allergy to maribavir or its components
- Severe gastrointestinal illness or absorption problems prior to dosing
- Need for mechanical ventilation or vasopressors at baseline
- Pregnant or nursing individuals
- Prior participation or withdrawal from this study
- Use of investigational agents or devices within 30 days before treatment
- Previous treatment with maribavir or CMV vaccine
- Any medical or surgical condition interfering with study or safety
- Severe liver disease or abnormal liver function tests
- Positive HIV test
- Active malignancy except nonmelanoma skin cancer or relapse of underlying malignancy
- Treatment for acute or chronic hepatitis B or C
- Need for strong CYP3A inducers
- Low body weight causing excessive blood volume withdrawal during study visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 8 weeks
Participants receive maribavir orally twice daily according to body weight for up to 8 weeks to treat CMV infection after stem cell or organ transplant.
Multiple visits including pharmacokinetic sampling on Day 7 (Week 1), Day 28 (Week 4), and Day 56 (Week 8)
Follow-up
Duration - Up to 12 weeks
Participants are monitored for safety, antiviral activity, and potential recurrence of CMV infection for up to 12 weeks after treatment ends.
Visits at Weeks 12, 16, and 20 post-treatment
Trial Site Locations
Total: 53 locations
1
Nemours Children's Health - Wilmington - PIN
Wilmington, Delaware, United States, 19803-3607
Actively Recruiting
2
Johns Hopkins All Children's Hospital - Main - PIN
St. Petersburg, Florida, United States, 33701
Actively Recruiting
3
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
Chicago, Illinois, United States, 60611
Actively Recruiting
4
University of Nebraska Medical Center -985400 Nebraska Medical Center
Omaha, Nebraska, United States, 68114-4113
Actively Recruiting
5
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States, 45229-3026
Actively Recruiting
6
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104-2733
Actively Recruiting
7
University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd
Houston, Texas, United States, 77030-4000
Actively Recruiting
8
Texas Children's Hospital - Wallace Tower - PIN
Houston, Texas, United States, 77030
Actively Recruiting
9
Minderoo Children's Comprehensive Cancer Centre
Randwick, New South Wales, Australia, 2031
Actively Recruiting
10
Queensland Children's Hospital
Woollangabba, Queensland, Australia, 4101
Actively Recruiting
11
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia, 3052
Actively Recruiting
12
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
13
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Brussels Capital, Belgium, 1020
Actively Recruiting
14
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
Actively Recruiting
15
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
16
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Porto Alegre, Rio Grande do Sul, Brazil, 05403-000
Actively Recruiting
17
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
18
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
19
Hospital Do Rim E Hipertensão
São Paulo, Brazil, 04038-002
Actively Recruiting
20
Capital Center For Children's Healthy, Capital Medical University
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
21
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
22
The First Affiliated Hospital, Sun Yat-sen University - Main
Guangzhou, Guangdong, China, 510080
Actively Recruiting
23
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518038
Actively Recruiting
24
Shanghai Children's Medical Center - Zhangjiang Campus
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
25
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
26
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France, 35200
Actively Recruiting
27
CHU de Grenoble Alpes - Hôpital Michallon
La Tronche, Isère, France, 38700
Actively Recruiting
28
CHRU Nantes
Nantes, Loire-Atlantique, France, 44000
Actively Recruiting
29
Hopital Necker
Paris, France, 75015
Actively Recruiting
30
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
31
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
32
Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
Jena, Thuringia, Germany, 07745
Actively Recruiting
33
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
34
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
35
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, Israel, 52394
Actively Recruiting
36
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Tel Aviv, Israel, 64239
Actively Recruiting
37
Rambam Health Care Campus - PPDS
Haifa, Israel, 31096
Actively Recruiting
38
Hadassah Medical Center- Ein Kerem - PPDS
Petah Tikva, Israel, 4920235
Actively Recruiting
39
Saitama Prefectural Children's Medical Center
Saitama-Shi Chuo-Ku, Saitama, Japan, 330-8777
Actively Recruiting
40
Shizuoka Children's Hospital
Aoi-ku, Shizuoka, Japan, 420-8660
Actively Recruiting
41
National Center for Child Health and Development
Setagaya-Ku, Tokyo, Japan, 157-8535
Actively Recruiting
42
Hyogo Prefectural Kobe Children's Hospital
Chiba, Japan, 650-0047
Actively Recruiting
43
Osaka Women's and Children's Hospital
Izumi-Shi, Ôsaka, Japan, 594-1101
Actively Recruiting
44
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
45
Hospital Universitario La Paz - PPDS
Horcajo de la Sierra, Madrid, Spain, 28755
Actively Recruiting
46
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Málaga, Málaga, Spain, 29011
Actively Recruiting
47
Hospital Universitario Vall d´Hebron- PPDS
Barcelona, Spain, 08035
Actively Recruiting
48
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, Spain, 28009
Actively Recruiting
49
King's College Hospital
London, Lambeth, United Kingdom, SE5 9RS
Actively Recruiting
50
Royal Manchester Children's Hospital - PIN
Manchester, Lancashire, United Kingdom, M13 9WL
Actively Recruiting
51
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Actively Recruiting
52
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B4 6NH
Actively Recruiting
53
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
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Research Team
T
Takeda 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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