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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
Positive congenital CMV by urine culture or polymerase chain reaction test(PCR), OR saliva culture or PCR followed by confirmatory urine PCR by 21 days of age, OR urine culture or PCR after 21 days of age followed by newborn dry blood spot PCR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, 8, 14 and 20 months post-randomization
Awards & highlights

ValEAR Trial 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.Check my eligibility
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.See study design
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.

ValEAR Trial Eligibility Criteria

Inclusion Criteria

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

ValEAR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Ear Hearing Slope
Secondary outcome measures
Best Ear Hearing Slope
Percentile Score for Words Produced Endpoint
Other outcome measures
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

ValEAR 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
325 Previous Clinical Trials
178,108 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,628 Total Patients Enrolled
Albert ParkLead Sponsor

Media Library

Valganciclovir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT03107871 — Phase 2
Sensorineural Hearing Loss Research Study Groups: Arm A, Arm B
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this particular test be appropriate for patients who are octogenarians?

"To be eligible for this clinical trial, patients must between the ages of 1 month to 12 months old. There are a total of 66 studies currently ongoing for children under 18 and 160 for adults over 65 years old."

Answered by AI

Are there any dangerous side effects associated with Valganciclovir?

"While there is some data supporting Valganciclovir's safety, it did not receive a higher score because efficacy has yet to be demonstrated in clinical trials."

Answered by AI

Could I qualify to take part in this research?

"To qualify for this study, infants between the ages of 1 month and 12 months must have cmv. This trial has space for around 52 participants."

Answered by AI

Are there still positions available in this clinical trial?

"As of right now, this study is not looking for any more participants. However, it's important to note that this could change in the future as the study was last edited on February 22nd, 2022. If you're interested in participating in other studies, there are 176 trials involving cmv and 28 Valganciclovir trials that are currently enrolling patients."

Answered by AI

How many participants will this research project be able to accommodate?

"At the moment, this clinical trial is not enrolling patients. The date of the original posting was August 31st, 2018 and February 22nd, 2020 marks the most recent update. There are 28 other trials recruiting participants who have cmv and Valganciclovir respectively."

Answered by AI

Are there other areas of research in which Valganciclovir has been used?

"Valganciclovir was first trialled in 2004 at the National Institutes of Health Clinical Center. In the 16 years since, there have been 101 completed clinical trials with valganciclovir. Right now, 28 different medical studies are using this medication with a large portion taking place in Ottawa and California."

Answered by AI

How many different hospitals are participating in this trial?

"In addition to other sites, this trial is accepting patients from Children's Hospital of Eastern Ontario in Ottawa, California, Hospital for Sick Children in Toronto, Michigan and McMaster University in Hamilton."

Answered by AI

What are Valganciclovir's common applications in medication?

"Valganciclovir is often given to patients with AIDS, however it can also help those with cytomegalovirus retinitis, kidney transplants, and lung transplants."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
What site did they apply to?
University of Iowa
Children's Mercy Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

~8 spots leftby Mar 2025