Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT02606266
Eligibility Criteria:
Inclusion Criteria:
* Children ≥ 6 months old and \< 12 years old
* Past history of proven congenital CMV infection
* Auditory threshold of between 40 and 90 dB in at least 1 ear.
Exclusion Criteria:
* Bilateral deafness \> 90 dB
* Contraindication to valganciclovir, particularly: Neutropenia with a known neutrophil count of \<500/mm3, Hb\<8g/dl or platelets\< 25,000/mm3 (FBC to be confirmed before randomisation)
* Past history of neutropenia on valganciclovir or allergy to the compound
* Renal impairment with creatinine clearance of \< 10 ml/min/1.72m2 (confirmation of renal function before randomisation) according to the Schwartz equation
* Patients on other antiviral treatment
* Gastrointestinal absorption problems
* Patients participating in a biomedical research project on a medicinal product or similar product
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Years
Study:
NCT02606266
Study Brief:
Protocol Section:
NCT02606266