NCT05137717

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

A Phase 3, Open-Label, Single-Arm Study to Assess the Efficacy, Safety, and Pharmacokinetics of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Japanese Recipients of a Hematopoietic Stem Cell Transplant (HSCT) or Solid Organ Transplant (SOT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it. Japanese recipients of a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) will take Maribavir tablets two times a day for 8 weeks in this study. During the study, participants will visit their study clinic 18 times as a maximum.

Conditions

• Cytomegalovirus (CMV)

Interventions

Type	Name	Description
DRUG	Maribavir	Maribavir tablets

Timeline

• Start date: 2022-01-18
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2021-11-30
• Last updated: 2024-07-09
• Results posted: 2024-07-09

Locations

20 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study