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

Cytomegalovirus (CMV) Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05319353
Study type	Interventional
Source	Takeda
Contact	Takeda Contact
Phone	+1-877-825-3327
Email	medinfoUS@takeda.com
Status	Recruiting
Phase	Phase 3
Start date	November 13, 2023
Completion date	November 22, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05571137` - A Study on Cytomegalovirus (CMV) Infection Outcomes Among Hematopoietic Stem Cell Transplant (HSCT) Participants in Europe and Canada
Not yet recruiting	`NCT06243731` - A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
Completed	`NCT05576805` - A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada
Not yet recruiting	`NCT06213974` - A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
Completed	`NCT02775240` - Study of SHP620 (Maribavir) in Healthy Adults	Phase 1
Completed	`NCT01611974` - Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients	Phase 2
Completed	`NCT05137717` - A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection	Phase 3
Completed	`NCT02931539` - Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir	Phase 3
Completed	`NCT02927067` - A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants	Phase 3