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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)
Sponsor: Takeda
Summary
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.
Official title: A Phase 3, Open-label, Single-arm, Repeated-dose 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)
Key Details
Gender
All
Age Range
Any - 17 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-11-13
Completion Date
2027-01-18
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
Maribavir
Participants will receive maribavir.
Locations (47)
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