At a glance
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A Phase II Randomized and Controlled Investigation of Six Weeks of Oral Valganciclovir Therapy in Infants and Children With Congenital Cytomegalovirus Infection and Hearing Loss
In Brief
A Phase 2 clinical trial evaluating Placebo and Valganciclovir for Cytomegalovirus Infection. Completed, enrolled 54 participants across 18 sites in 2 countries.
Detailed Summary
This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Subject participation will be over a six-month period and study subjects will be stratified according to age. The primary objective is to assess whether a six-week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss.
Study Details
Timeline
Interventions
Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks
Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.