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)

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.

NCT Number	NCT05319353
Lead Sponsor	Takeda Collaborators: Takeda Development Center Americas, Inc.
Conditions	Cytomegalovirus (CMV)
Enrollment	80 participants
Start Date	2023-11-13
Primary Completion	2027-01-18 (estimated)
Study Completion	2027-01-18 (estimated)
Updated on ClinicalTrials.gov	2026-05-22