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)

NCT05319353 ↗

Phase 3 Recruiting 80 enrolled Takeda Takeda Development Center Americas, Inc. · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2023-11-13
Primary completion: 2027-01-18
Completion: 2027-01-18

Publications

Fisher JE, Mulieri K, Finch E, Ericson JE. Use of Maribavir for Multidrug Resistant Cytomegaloviremia in a Pediatric Oncology Patient. J Pediatr Hematol Oncol. 2024 Apr 1;46(3):e244-e247. doi: 10.1097/MPH.0000000000002841. Epub 2024 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Maribavir	Small molecule	50 mg	Oral
Subject	Maribavir	Small molecule	100 mg	Oral
Subject	Maribavir	Small molecule	200 mg	Oral
Subject	Maribavir	Small molecule	400 mg	Oral

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)

Summary

Timeline

Publications

Drugs

Indications