Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can an antiviral drug protect hearing in infants with congenital CMV?

NCT ID NCT03107871

Disease control Sponsor: Albert Park Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether the antiviral drug valganciclovir can improve hearing and language outcomes in infants who have hearing loss due to congenital cytomegalovirus (CMV) infection. Infants aged 1 to 12 months with confirmed sensorineural hearing loss will receive either valganciclovir or a placebo for a period, and researchers will track their hearing thresholds and language development over 20 months. The study also monitors the safety of the drug in this specific group of infants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
valganciclovir, an antiviral drug
What this could lead to
If it works, this could point toward a treatment that slows or prevents further hearing loss and supports language development in infants with congenital CMV.
What could go wrong
This is a small early-stage trial, so results may not hold up in larger studies. The drug can cause side effects like low blood cell counts, and not all infants may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Aug 2018

Finished

Aug 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 12 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age greater than or equal to 1 month and less than or equal to 12 months at the time of randomization; AND * 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; AND * 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. Exclusion Criteria: * Imminent demise; OR * Known hypersensitivity reaction to valganciclovir, ganciclovir, or any components of the investigational product formulation; OR * ALT (Alanine Aminotransferase) five times baseline U/L, hepatomegaly, or significant gastrointestinal disorders (e.g., eosinophilic esophagitis, ulcerative colitis); OR * Absolute neutrophil count (ANC) less than 500 cells/mm\^3, Hemoglobin less than 8 g/dL, or platelets less than 50,000/mm\^3, splenomegaly, or significant hematologic disorders (e.g., hemophilia, leukemia, sickle cell anemia); OR * Creatinine clearance less than 60 mL/min/1.73m\^2 or significant renal disorders (e.g., nephrotic syndrome); OR * Receiving other antiviral medications or immune globulin therapy; OR * Receiving other investigational drugs; OR * Breast feeding from a mother receiving antiviral or immunosuppressive medication; OR * Known HIV positive mother (risk of immunosuppression); OR * Subject is currently using list of prohibited medication specified by the package insert; OR * Other known cause contributing to SNHL (e.g., meningitis, aminoglycoside ototoxicity); OR * Bilateral profound SNHL or auditory neuropathy spectrum disorder; OR * Existing conductive hearing loss or mixed permanent hearing loss is present; OR * Evidence of intracranial calcification; OR * Evidence of hydrocephalus; OR * Microcephaly; OR * Presence of petechiae; OR * Intrauterine growth retardation; OR * Chorioretinitis, optic atrophy or pale optic nerves; OR * Parent or guardian unable to speak English or Spanish; OR * Subject exposed to a language other than English or Spanish a majority of the time; OR * Subject unable to complete hearing assessments or parent/guardian unable to complete communication questionnaires; OR * \< 32 weeks gestational age at birth; OR * Weight at the time of birth \< 1800 g.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for CMV are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

cytomegalovirus infection fetal cytomegalovirus syndrome Hearing Loss, Sensorineural sensorineural hearing loss disorder X-linked mixed hearing loss with perilymphatic gusher

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CMV CMV congenital Congenital CMV Sensorineural hearing loss SNHL

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Children's Hospital at Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Cohen Children's Medical Center

    New York, New York, 11040, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94304, United States

  • Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232, United States

  • Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84132, United States

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123, United States

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203, United States

  • Saint Louis Universtiy

    St Louis, Missouri, 63103, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10469, United States

  • UCSF Benioff Children's Hospital

    San Francisco, California, 94158, United States

  • UT Southwestern

    Dallas, Texas, 75235, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Minnesota Masonic Children's Hospital

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.