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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


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

See also
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Not yet recruiting NCT06243731 - A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
Not yet recruiting NCT06439342 - A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections Phase 3
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