Efficacy and safety of valganciclovir treatment for late-onset hearing impairment due to congenital cytomegalovirus infection (VGCV-3)

Recruiting

• Conditions: Congenital cytomegalovirus infection (late-onset hearing impairment)

• Registration Number: jRCT2051240269

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-13
• Study Start: 2025-05-14
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Confirmation of positive CMV-DNA amplification in urine by an in vitro diagnostic test within 21 days of age or in dried umbilical cord tissue or dried filter paper blood
2. Patients who were asymptomatic at birth but developed late-onset hearing impairment after 21 days of age, or patients who were symptomatic at birth but did not have any hearing impairment and subsequently developed late-onset hearing impairment
3. Patients with a degree of impairment of at least 30 dB and less than 90 dB in at least one ear at the time of screening
4. Under four years old at the time of obtaining informed consent
5. Signed informed consent from parents or legal guardians

Exclusion Criteria

1. Patients with bacterial infection requiring antibiotics at the time of study enrollment
2. Renal insufficiency (serum creatinine level > 1.5 mg/dL) at the time of study enrollment
3. Encephalopathy and hydrocephalus owing to other causes
4. Patients with inner ear malformations such as enlarged vestibular aqueducts, middle ear malformations, and middle ear diseases such as cholesteatoma
5. Mumps deafness
6. Hereditary or progressive central deafness
7. Patients who have received treatment with an antiviral drug (such as ganciclovir or valganciclovir) for CMV in the past. However, this is acceptable for temporary treatment of active or acute lesions.
8. Neutrophil count < 500/mm3 or platelet count < 25,000/mm3
9. Infants born to women with human immunodeficiency virus (HIV) or infants with HIV
10. Patients receiving breast milk from mothers who are taking antiviral or immunosuppressive drugs
11. Patients who have received other investigational drugs before registration, or who plan to participate in other clinical trials during the period of participation in the clinical trial
12. Patients deemed inappropriate by a study investigator or sub-investigators

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Hearing improvement in ABR (total ear hearing assessments) or ASSR after 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Changes in hearing impairment levels in ABR (total ear hearing assessments)	after 6 weeks and 6 months of treatment	Changes in hearing impairment levels in ABR (total ear hearing assessments)
Hearing improvement in ABR or ASSR (total ear hearing assessments)	after 6 weeks of treatment	Hearing improvement in ABR or ASSR (total ear hearing assessments)
CMV load in urine during the study period and its change from baseline		CMV load in urine during the study period and its change from baseline
Change in hearing impairment levels in ABR (best response ear hearing assessments)	after 6 weeks and 6 months of treatment	Change in hearing impairment levels in ABR (best response ear hearing assessments)
Changes in hearing impairment levels in ASSR for each frequency (500Hz, 1000Hz, 2000Hz, 4000Hz) (both best response ear and total ear hearing assessments)	after 6 months of treatment	Changes in hearing impairment levels in ASSR for each frequency (500Hz, 1000Hz, 2000Hz, 4000Hz) (both best response ear and total ear hearing assessments)
CMV load in whole blood during the study period and its change from baseline		CMV load in whole blood during the study period and its change from baseline
CMV load in plasma during the study period and its change from baseline		CMV load in plasma during the study period and its change from baseline
Improvement of thrombocytopenia, liver function disorder, and retinitis		Improvement of thrombocytopenia, liver function disorder, and retinitis
Adverse events		Adverse events
Adverse drug reactions		Adverse drug reactions
Hearing improvement in ABR or ASSR (best response ear hearing assessments)	after 6 weeks and 6 months of treatment	Hearing improvement in ABR or ASSR (best response ear hearing assessments)