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Antiviral

Valganciclovir for Cytomegalovirus-Related Hearing Loss (ValEAR Trial)

Phase 2
Waitlist Available
Led By Albert Park, MD
Research Sponsored by Albert Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 1 month and less than or equal to 12 months at the time of randomization
Confirmed sensorineural hearing loss (SNHL) by auditory brainstem response (ABR) testing. For ABR assessments, hearing loss is defined as levels greater than 25 dB normal hearing levels (NHL) at 1, 2, or 4 kHz in one or both ears.
Must not have
Parent or guardian unable to speak English or Spanish
ALT (Alanine Aminotransferase) five times baseline U/L, hepatomegaly, or significant gastrointestinal disorders (e.g., eosinophilic esophagitis, ulcerative colitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, 8, 14 and 20 months post-randomization

Summary

This trial will determine whether hearing-impaired infants with asymptomatic cCMV have better hearing and language outcomes if they receive valganciclovir antiviral treatment.

Who is the study for?
This trial is for infants aged 1-12 months with sensorineural hearing loss confirmed by ABR testing, who have asymptomatic congenital CMV. Infants must not have other causes of hearing loss, be on certain medications, or have various health conditions like severe liver problems, low blood counts, or significant kidney issues.
What is being tested?
The study tests if the antiviral drug Valganciclovir improves hearing and language in infants with cCMV-related hearing loss compared to a placebo (simple syrup). It's a double-blind trial meaning neither doctors nor participants know who gets the real medicine versus the placebo.
What are the potential side effects?
Potential side effects of Valganciclovir include allergic reactions, changes in blood cell counts which can increase infection risk or cause anemia and bleeding issues, liver function changes, and gastrointestinal problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 month and 12 months old.
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I have been diagnosed with hearing loss through ABR testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My parent or guardian does not speak English or Spanish.
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My liver enzyme levels are high, or I have liver enlargement or serious gut issues.
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I was born before reaching 32 weeks of pregnancy.
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I have permanent hearing loss that is not solely due to nerve issues.
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I have low blood counts or a significant blood disorder.
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My kidney function is reduced or I have a significant kidney disorder.
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I am currently taking antiviral medications or receiving immune globulin therapy.
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My birth weight was less than 1800 grams.
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I have severe hearing loss in both ears.
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I have small red or purple spots on my skin.
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I have eye conditions like inflammation, optic nerve damage, or pale optic nerves.
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My hearing loss is not due to meningitis or medication damage.
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I am breastfeeding and taking antiviral or immunosuppressive medication.
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I am not taking any medications that are not allowed in this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, 8, 14 and 20 months post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, 8, 14 and 20 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total Ear Hearing Slope
Secondary study objectives
Best Ear Hearing Slope
Percentile Score for Words Produced Endpoint
Other study objectives
Additional MacArthur Bates - Words and Sentences Subscale Percentiles
Developmental Domain Endpoints
LittlEARS
+5 more

Side effects data

From 2015 Phase 4 trial • 40 Patients • NCT01509404
50%
Leukopenia
30%
Acute rejection
25%
BK infection
20%
CMV disease
15%
Candidiasis
5%
Thrombocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Valcyte Then Cytogam
Valcyte

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Group II: Arm BPlacebo Group1 Intervention
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valganciclovir
2019
Completed Phase 4
~2160

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
182,006 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,948 Total Patients Enrolled
Albert ParkLead Sponsor
Albert Park, MDPrincipal Investigator - University of Utah
Intermountain Medical Center, Primary Children's Hospital, University of Utah Hospital
Washington University School Of Medicine (Medical School)
F G Mc Gaw Hp/Loyola University (Residency)

Media Library

Valganciclovir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT03107871 — Phase 2
Sensorineural Hearing Loss Research Study Groups: Arm B, Arm A
Sensorineural Hearing Loss Clinical Trial 2023: Valganciclovir Highlights & Side Effects. Trial Name: NCT03107871 — Phase 2
Valganciclovir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03107871 — Phase 2
~7 spots leftby Dec 2025
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