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A clinical trial for the efficacy and safety of valganciclovir in patients with late-onset hearing impairment due to congenital cytomegalovirus infection - a multicenter, randomized, double-blinded, placebo-controlled clinical trial (VGCV-3)

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

Fujioka Kazumichi

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017 Japan

fujiokak@med.kobe-u.ac.jp

Kodama Tomoyuki

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017 Japan

+81-78-382-6729

ctrcpj-vgcv@med.kobe-u.ac.jp

Recruiting

Mar. 01, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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

Both

Congenital cytomegalovirus infection (late-onset hearing impairment)

<Valganciclovir group>
Valganciclovir 16 mg/kg is to be continuously administered twice daily for 6 months.

<Placebo group>
Equivalent dose (mL) of valganciclovir (16 mg/kg) which be calculated based on body weight is to be continuously administered twice daily for 6 months.

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

<Secondary outcomes>
1. Hearing improvement in ABR or ASSR (total ear hearing assessments) after 6 weeks of treatment
2. Hearing improvement in ABR or ASSR (best response ear hearing assessments) after 6 weeks and 6 months of treatment
3. Changes in hearing impairment levels in ABR (total ear hearing assessments) after 6 weeks and 6 months of treatment
4. Change in hearing impairment levels in ABR (best response ear hearing assessments) after 6 weeks and 6 months of treatment
5. 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
6. CMV load in whole blood during the study period and its change from baseline
7. CMV load in plasma during the study period and its change from baseline
8. CMV load in urine during the study period and its change from baseline
9. Improvement of thrombocytopenia, liver function disorder, and retinitis

<Safety outcomes>
Adverse events, Adverse drug reactions

+81-78-382-6669

Feb. 10, 2025

Yes

Share upon reasonable request.

None