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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT01649869
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent from parent(s) or legal guardian(s)
2. Sensorineural hearing loss (\>/= 21dB in one or both ears, documented within 12 weeks prior to study entry)
3. Children from 1 month through 3 years of age (up to the 4th birthday)
Exclusion Criteria:
1. Imminent demise
2. Profound sensorineural hearing loss (\> 90dB) in both ears
3. Patients receiving other antiviral agents or immune globulin
4. Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
5. Documented renal insufficiency, as noted by a creatinine clearance \< 10 mL/min/1.73m2 at time of study enrollment
6. Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribavir
7. Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).
8. Current receipt of other investigational drugs
9. Previous receipt of ganciclovir or valganciclovir
10. Known hypersensitivity to ganciclovir, valganciclovir, or components of the product
11. Inability to attend follow-up hearing and clinical assessments
12. Infants with Auditory neuropathy/dyssynchrony.
13. Children with another known etiology for SNHL (e.g. connexin 26, syndrome or metabolic disorder associated with SNHL, inner ear malformation and widened vestibular aqueducts, meningitis).
Exclusion of each of these conditions is not required for trial enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
4 Years
Study:
NCT01649869
Study Brief:
Protocol Section:
NCT01649869