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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Maribavir: Participants will receive maribavir.
Study 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
Primary outcome measure(s)
- Maximum Observed Plasma Concentration (Cmax) of Maribavir — Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
Cmax of maribavir will be evaluated. - Time to Maximum Observed Concentration (Tmax) of Maribavir — Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
Tmax of maribavir will be evaluated. - Minimum Plasma Concentration (Cmin) of Maribavir — Pre-dose; (0.5, 1.5, 3, 4, 6, and 8 hours post-dose) on Day 7 (Week 1); Pre-dose on Day 28 (Week 4); Pre-dose; (2 to 4 hours post-dose) on Day 56 (Week 8)
Cmin of maribavir will be evaluated. - Area Under the Plasma Concentration-Time Curve Over the 1 Dosing Interval of 12 Hours at Steady State (AUC0-tau) of Maribavir — Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
AUC0-tau of maribavir will be evaluated. - Half-Life (t1/2) of Maribavir — Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
t1/2 of maribavir will be evaluated. - Terminal Elimination Rate Constant (lambdaz) of Maribavir — Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
Lambdaz of maribavir will be evaluated. - Apparent Volume of Distribution (Vz/F) of Maribavir — Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
Vz/F of maribavir will be evaluated. - Apparent Oral Clearance (CL/F) of Maribavir — Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
CL/F of maribavir will be evaluated. - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — From start of study drug administration up to follow-up (Week 20)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily be considered related to investigational product. SAE is any untoward medical occurrence (whether considered related to investigational product or not) that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, or is an important medical event.
Trial sites (53)
| Facility | City | Region | Status |
|---|---|---|---|
| Nemours Children's Health - Wilmington - PIN | Wilmington | Delaware | Recruiting |
| Johns Hopkins All Children's Hospital - Main - PIN | St. Petersburg | Florida | Recruiting |
| Ann and Robert H Lurie Childrens Hospital of Chicago - PIN | Chicago | Illinois | Recruiting |
| University of Nebraska Medical Center -985400 Nebraska Medical Center | Omaha | Nebraska | Recruiting |
| Cincinnati Children's Hospital Medical Center - PIN | Cincinnati | Ohio | Recruiting |
| Cook Children's Health Care System | Fort Worth | Texas | Recruiting |
| University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd | Houston | Texas | Recruiting |
| Texas Children's Hospital - Wallace Tower - PIN | Houston | Texas | Recruiting |
| Minderoo Children's Comprehensive Cancer Centre | Randwick | New South Wales | Recruiting |
| Queensland Children's Hospital | Woollangabba | Queensland | Recruiting |
| Royal Children's Hospital Melbourne - PIN | Parkville | Victoria | Recruiting |
| Perth Children's Hospital | Nedlands | Western Australia | Recruiting |
| Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) | Brussels | Brussels Capital | Recruiting |
| Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Brussels Capital | Recruiting |
| UZ Gent | Ghent | Oost-Vlaanderen | Recruiting |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Porto Alegre | Rio Grande do Sul | Recruiting |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital de Clinicas de Porto Alegre (HCPA) - PPDS | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital Do Rim E Hipertensão | São Paulo | Brazil | Recruiting |
| Capital Center For Children's Healthy, Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| Beijing Children's Hospital, Capital Medical University - PIN | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University - Main | Guangzhou | Guangdong | Recruiting |
| Shenzhen Children's Hospital | Shenzhen | Guangdong | Recruiting |
| Shanghai Children's Medical Center - Zhangjiang Campus | Shanghai | Shanghai Municipality | Recruiting |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS | Tianjin | Tianjin Municipality | Recruiting |
| CHU de Rennes - Hôpital Pontchaillou | Rennes | Ille-et-Vilaine | Recruiting |
| CHU de Grenoble Alpes - Hôpital Michallon | La Tronche | Isère | Recruiting |
| CHRU Nantes | Nantes | Loire-Atlantique | Recruiting |
| Hopital Necker | Paris | France | Recruiting |
| Universitätsklinikum Würzburg | Würzburg | Bavaria | Recruiting |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | Recruiting |
| Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101 | Jena | Thuringia | Recruiting |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Germany | Recruiting |
| The Chaim Sheba Medical Center - PPDS | Ramat Gan | Tel Aviv | Recruiting |
| Tel Aviv Sourasky Medical Center Ichilov - PPDS | Tel Aviv | Tel Aviv | Recruiting |
| Rambam Health Care Campus - PPDS | Haifa | Israel | Recruiting |
| Hadassah Medical Center- Ein Kerem - PPDS | Petah Tikva | Israel | Recruiting |
| Saitama Prefectural Children's Medical Center | Saitama-Shi Chuo-Ku | Saitama | Recruiting |
| Shizuoka Children's Hospital | Aoi-ku | Shizuoka | Recruiting |
+ 13 more sites — see the full list on the official registry below.
More Takeda trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05319353 on ClinicalTrials.gov ↗ ← All trials in Spain