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RECRUITING
NCT05319353
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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