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)

PHASE3RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 13, 2023

Primary Completion Date

January 18, 2027

Study Completion Date

January 18, 2027

Conditions
Cytomegalovirus (CMV)
Interventions
DRUG

Maribavir

Participants will receive maribavir.

Trial Locations (47)

1020

RECRUITING

Hôpital Universitaire des Enfants Reine Fabiola (HUDERF), Brussels

1200

RECRUITING

Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

2031

RECRUITING

Sydney Children's Hospital, Randwick

3052

RECRUITING

Royal Children's Hospital Melbourne - PIN, Parkville

4101

RECRUITING

Queensland Children's Hospital, South Brisbane

6009

RECRUITING

Perth Children's Hospital, Nedlands

9000

RECRUITING

UZ Gent, Ghent

20246

RECRUITING

Universitätsklinikum Hamburg Eppendorf, Hamburg

28009

RECRUITING

Hospital Infantil Universitario Niño Jesus - PIN, Madrid

28755

RECRUITING

Hospital Universitario La Paz - PPDS, Horcajo de la Sierra

29011

RECRUITING

Hospital Regional Universitario de Malaga - Hospital Materno-Infantil, Málaga

30625

RECRUITING

Medizinische Hochschule Hannover, Hanover

31096

RECRUITING

Rambam Health Care Campus - PPDS, Haifa

35200

RECRUITING

CHU de Rennes - Hôpital Pontchaillou, Rennes

38700

RECRUITING

CHU de Grenoble Alpes - Hôpital Michallon, La Tronche

44000

RECRUITING

CHRU Nantes, Nantes

48149

RECRUITING

Universitätsklinikum Münster, Münster

52394

RECRUITING

The Chaim Sheba Medical Center - PPDS, Ramat Gan

64239

RECRUITING

Tel Aviv Sourasky Medical Center Ichilov - PPDS, Tel Aviv

75015

RECRUITING

Hopital Necker, Paris

97080

RECRUITING

Universitätsklinikum Würzburg, Würzburg

100020

RECRUITING

Children's Hospital Capital Institute of Pediatrics, Beijing

100045

RECRUITING

Beijing Children's Hospital, Capital Medical University - PIN, Beijing

200127

RECRUITING

Shanghai Children's Medical Center, Shanghai

300020

RECRUITING

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS, Tianjin

4920235

RECRUITING

Hadassah Medical Center- Ein Kerem - PPDS, Petah Tikva

68114-4113

RECRUITING

University of Nebraska Medical Center -985400 Nebraska Medical Center, Omaha

45229-3026

RECRUITING

Cincinnati Children's Hospital Medical Center - PIN, Cincinnati

76104-2733

RECRUITING

Cook Children's Health Care System, Fort Worth

77030-4000

RECRUITING

University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd, Houston

90020-090

RECRUITING

Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90035-903

RECRUITING

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre

90160-093

RECRUITING

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Porto Alegre

04038-002

RECRUITING

Hospital Do Rim E Hipertensão, São Paulo

07745

RECRUITING

Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101, Jena

453-0046

RECRUITING

National Center for Child Health and Development, Nagoya

259-1143

RECRUITING

Saitama Children's Medical Center, Isehara-Shi

420-8660

RECRUITING

Shizuoka Children's Hospital, Aoi-ku

650-0047

RECRUITING

Hyogo Prefectural Kobe Children's Hospital, Chiba

594-1101

RECRUITING

Osaka Women's and Children's Hospital, Izumi-Shi

08950

RECRUITING

Hospital Sant Joan de Deu - PIN, Espluges de Llobregat

08035

RECRUITING

Hospital Universitario Vall d´Hebron- PPDS, Barcelona

SE5 9RS

RECRUITING

King's College Hospital, London

M13 9WL

RECRUITING

Royal Manchester Children's Hospital - PIN, Manchester

NG5 1PB

RECRUITING

Nottingham University Hospitals NHS Trust, Nottingham

B4 6NH

RECRUITING

Birmingham Women's and Children's NHS Foundation Trust, Birmingham

WC1N 3JH

RECRUITING

Great Ormond Street Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

Takeda

INDUSTRY

NCT05319353 - 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) | Biotech Hunter | Biotech Hunter