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A Phase 1 Pharmacokinetic and Safety Assessment of Oral Letermovir in Infants with Symptomatic Congenital Cytomegalovirus Disease

Recruiting

The purpose of this study is to determine the dose of a new medication being studied for babies who are exposed to cytomegalovirus during birth. This is called congenital cytomegalovirus (cCMV). Cytomegalovirus is the leading cause of hearing loss and the leading viral cause of developmental delays in children. If a baby participates in this study, in addition to the study medication, he/she will still receive the current best treatment for cCMV, which is oral Valganciclovir.

I'm interested

Male or Female
Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age at enrollment is 90 days or younger
• gestational age at birth is 32 weeks or greater
• diagnosis or symptomatic congenital CMV (cytomegalovirus)
• minimum weight of 2.6kg (5 lb, 12 oz.)
Exclusion Criteria:

• receiving other investigation drug
• high bilirubin or ALT

Drug: Letermovir

Infectious Diseases

CMV, congenital, cytomegalovirus, treatment, valgancyclovir

Mark Schleiss - schleiss@umn.edu
Mark Schleiss
PHASE1
STUDY00021875
See this study on ClinicalTrials.gov

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