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)
Start Date
11/13/2023
Completion Date
1/18/2027
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.
Eligibility Criteria
Age Range: No minimum to 17 years
Interventions
Maribavir
Conditions
Locations
Nemours Children's Health - Wilmington - PIN
Wilmington, Delaware 19803-3607
United States
Johns Hopkins All Children's Hospital - Main - PIN
St. Petersburg, Florida 33701
United States
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
Chicago, Illinois 60611
United States
University of Nebraska Medical Center -985400 Nebraska Medical Center
Omaha, Nebraska 68114-4113
United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio 45229-3026
United States
Cook Children's Health Care System
Fort Worth, Texas 76104-2733
United States
University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd
Houston, Texas 77030-4000
United States
Texas Children's Hospital - Wallace Tower - PIN
Houston, Texas 77030
United States
Minderoo Children's Comprehensive Cancer Centre
Randwick, New South Wales 2031
Australia
Queensland Children's Hospital
Woollangabba, Queensland 4101
Australia
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria 3052
Australia
Perth Children's Hospital
Nedlands, Western Australia 6009
Australia
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Brussels Capital 1020
Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital 1200
Belgium
UZ Gent
Ghent, Oost-Vlaanderen 9000
Belgium
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Porto Alegre, Rio Grande do Sul 05403-000
Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul 90020-090
Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Hospital Do Rim E Hipertensão
São Paulo, 04038-002
Brazil
Capital Center For Children's Healthy, Capital Medical University
Beijing, Beijing Municipality 100020
China
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, Beijing Municipality 100045
China
The First Affiliated Hospital, Sun Yat-sen University - Main
Guangzhou, Guangdong 510080
China
Shenzhen Children's Hospital
Shenzhen, Guangdong 518038
China
Shanghai Children's Medical Center - Zhangjiang Campus
Shanghai, Shanghai Municipality 200127
China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
Tianjin, Tianjin Municipality 300020
China
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine 35200
France
CHU de Grenoble Alpes - Hôpital Michallon
La Tronche, Isère 38700
France
CHRU Nantes
Nantes, Loire-Atlantique 44000
France
Hopital Necker
Paris, 75015
France
Universitätsklinikum Würzburg
Würzburg, Bavaria 97080
Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia 48149
Germany
Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
Jena, Thuringia 07745
Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv 52394
Israel
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Tel Aviv 64239
Israel
Rambam Health Care Campus - PPDS
Haifa, 31096
Israel
Hadassah Medical Center- Ein Kerem - PPDS
Petah Tikva, 4920235
Israel
Saitama Prefectural Children's Medical Center
Saitama-Shi Chuo-Ku, Saitama 330-8777
Japan
Shizuoka Children's Hospital
Aoi-ku, Shizuoka 420-8660
Japan
National Center for Child Health and Development
Setagaya-Ku, Tokyo 157-8535
Japan
Hyogo Prefectural Kobe Children's Hospital
Chiba, 650-0047
Japan
Osaka Women's and Children's Hospital
Izumi-Shi, Ôsaka 594-1101
Japan
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona 08950
Spain
Hospital Universitario La Paz - PPDS
Horcajo de la Sierra, Madrid 28755
Spain
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
Málaga, Málaga 29011
Spain
Hospital Universitario Vall d´Hebron- PPDS
Barcelona, 08035
Spain
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, 28009
Spain
King's College Hospital
London, Lambeth SE5 9RS
United Kingdom
Royal Manchester Children's Hospital - PIN
Manchester, Lancashire M13 9WL
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire NG5 1PB
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands B4 6NH
United Kingdom
Great Ormond Street Hospital
London, WC1N 3JH
United Kingdom