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)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus (CMV)

Interventions

Type	Name	Description
DRUG	Maribavir	Participants will receive maribavir.

Timeline

• Start date: 2023-11-13
• Primary completion: 2027-01-18
• Completion: 2027-01-18
• First posted: 2022-04-08
• Last updated: 2025-07-17

Locations

47 sites across 11 countries: United States, Australia, Belgium, Brazil, China, France, Germany, Israel, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study