CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 37 enrolled
Drug / intervention
Valganciclovirdrug
Likely dose
Valganciclovir 32 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02005822
NCT02005822Phase 3Completed
CompareCT.gov

The Leiden CONCERT Study 2.0 Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Non-Randomized Trial With Historical Control Group

Dr. Ann C.T.M. Vossen·interventional·Posted Dec 9, 2013·Updated Jun 3, 2021

In Brief

A Phase 3 clinical trial evaluating Valganciclovir for Congenital Cytomegalovirus Infection and Sensorineural Hearing Loss. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The objective of the trial is to investigate whether early treatment with oral valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can prevent progression of hearing loss.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Cytomegalovirus Infection, Sensorineural Hearing Loss
CountriesNetherlands
CollaboratorsStichting Nuts Ohra, Leiden University Medical Center

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 9, 2013
Enrollment StartOct 22, 2013
Primary CompletionMay 17, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.6 years ago

Interventions

Valganciclovirdrug

Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.