At a glance
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A Phase 2b Open-label, Single-arm Study to Evaluate Pharmacokinetics, Efficacy, Safety and Tolerability of Letermovir in Pediatric Participants From Birth to Less Than 18 Years of Age at Risk of Developing CMV Infection and/or Disease Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
In Brief
A Phase 2 clinical trial evaluating Letermovir oral granules, Letermovir tablet, and 1 other intervention for Cytomegalovirus (CMV) Infection. Completed, enrolled 65 participants across 40 sites in 11 countries.
Detailed Summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to \<18 years of age (adolescents); Age Group 2: From 2 to \<12 years of age (children); and Age Group 3: From birth to \<2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (\~100 days) post-transplant, with doses based on body weight and age.
Study Details
Timeline
Interventions
Granules administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
Tablet administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
Letermovir administered intravenously based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.