A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. 

The primary Objective is to determine the systemic exposure (AUC24) of letermovir following administration of oral letermovir granules in infants with symptomatic congenital CMV disease. the secondary objectives are 1.) To determine the other pharmacokinetic parameters of letermovir following administration of oral letermovir granules in infants with symptomatic congenital CMV disease; 2.) To evaluate the safety of letermovir oral granules in infants.

Visit ClinicalTrials.gov for details.

Participating in Research

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