Overview

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Children and Teenage Transplant Recipients With CMV Infection

Status:
Not yet recruiting

Trial end date:
2027-02-17

Target enrollment:

Participant gender:

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) adult tablet formulation or other formulation based on PK modeling. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.

Phase:

Phase 3

Details

Lead Sponsor:

Takeda

Collaborator:

Takeda Development Center Americas, Inc.

Treatments:

Maribavir