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)
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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