StudyFinder
A Phase 1 Pharmacokinetic and Safety Assessment of Oral Letermovir in Infants with Symptomatic Congenital Cytomegalovirus Disease
Status: 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.
Sex: Male or Female
Age Group: Up to 18 years old
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
Interventions:
Drug: Letermovir
Conditions:
Infectious Diseases
Keywords:
CMV, congenital, cytomegalovirus, treatment, valgancyclovir
Study Contact: Mark Schleiss - schleiss@umn.edu
Principal Investigator: Mark Schleiss
Phase: PHASE1
IRB Number: STUDY00021875
See this study on ClinicalTrials.gov