Cmv CongenitalPhase 2ValEARNCT03107871

Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants

A Phase 2 study testing Valganciclovir and Simple Syrup in people with Cmv Congenital and CMV, run by Albert Park at 30 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 month to 12 months
Conditions the study is for: Cmv Congenital, CMV, Congenital Cmv
What is being tested?: Valganciclovir and Simple Syrup
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 30 sitesUnited States
Study dates: 31 Aug 2018to 31 Aug 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 month to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Show all 24Show fewer

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.

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

University of New Mexico
Albuquerque, New Mexico, 87131
Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Medical University of South Carolina
Charleston, South Carolina, 29425
Lurie Children's Hospital
Chicago, Illinois, 60611
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern
Dallas, Texas, 75235
Baylor College of Medicine
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital at Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55455
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Weill Cornell Medicine
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Cohen Children's Medical Center
New York, New York, 11040
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Oregon Health and Science University
Portland, Oregon, 97239
Primary Children's Hospital
Salt Lake City, Utah, 84132
Rady Children's Hospital - San Diego
San Diego, California, 92123
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Seattle Children's Hospital
Seattle, Washington, 98105
Saint Louis Universtiy
St Louis, Missouri, 63103
The Children's Hospital at Montefiore
The Bronx, New York, 10469

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants: ValEAR Trial

The overall goal of this study is to determine the clinical benefit and safety of antiviral therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants. We will conduct a multi-center double-blind randomized placebo-controlled trial to determine whether hearing-impaired infants with asymptomatic cCMV have better hearing and language outcomes if they receive valganciclovir antiviral treatment. We will also determine the safety of antiviral valganciclovir therapy for asymptomatic cCMV-infected hearing impaired infants. This study will be unique in that the cohort enrolled will only include hearing-impaired infants with asymptomatic cCMV.

Primary Objective: To determine if treatment of cCMV-infected hearing impaired infants with isolated hearing loss with the antiviral drug valganciclovir reduces the mean slope of total hearing thresholds over the 20 months after randomization compared to untreated cCMV-infected infants with isolated hearing loss.

Main Secondary Objectives:

To determine if valganciclovir treatment improves the following outcomes when compared to the control group:
The slope of best ear hearing thresholds over the 20 months after randomization.
The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for words produced at 20 months of age.
To evaluate safety measures based on all grade 3 or greater new adverse events designated by the NIAID Division of AIDS (DAIDS) toxicity tables.

Read the detailed description

Cytomegalovirus (CMV) can be transmitted from the mother to the fetus and is a leading cause of sensorineural hearing loss (SNHL), which is a condition where the inner ear is unable to convert sound into nerve impulses to the brain. This hearing loss and its detrimental effect on language development contribute nearly $4 billion annually to the health care costs in the U.S. Unlike other types of SNHL, CMV induced hearing loss can be treated. Several clinical trials have demonstrated that antiviral therapy may prevent progressive hearing loss if administered early in life for severely affected (symptomatic CMV) infants. These promising findings have given rise to a debate regarding the best method for identifying and treating the more numerous asymptomatic CMV-infected infants.

One approach is to conduct universal newborn hearing screens, and then do CMV diagnostic testing only on the infants who fail the hearing screen. This targeted approach should identify those infants at greatest risk of developing progressive hearing loss and consequent communicative difficulties. Utah is the first state to mandate this approach whereby infants under three weeks of age who fail their newborn hearing screening undergo CMV testing. In this trial, the hearing screen targeted approach will be used to identify patients eligible for participation in a double blind placebo controlled randomized clinical trial of antiviral valganciclovir therapy. The results of this trial will inform public policy, potentially shift our current clinical practice regarding pediatric hearing loss evaluation, and potentially offer a therapeutic option to asymptomatic CMV-infected infants with SNHL.

Conditions: Cmv Congenital, CMV, Congenital Cmv, SNHL, Sensorineural Hearing Loss
Being tested: Valganciclovir, Simple Syrup
Keywords: valganciclovir
Medical subject headings: Cytomegalovirus Infections, Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ValganciclovirDrug
Also called Valcyte
Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
Simple SyrupDrug
Also called Sucrose Water
Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.

Study groups in NCT03107871
Study group	Role	What they receive
Arm A	Experimental	Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months Receives: Drug: Valganciclovir
Arm B	Placebo comparator	Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months Receives: Drug: Simple Syrup

What is being measured

The primary outcome is the main question the study is designed to answer.

Baseline Total Ear Hearing Thresholds
Baseline hearing thresholds were summarized descriptively using the average minimum response levels (MRLs) at 2 kHz and 4 kHz for each ear. Lower values indicate better hearing sensitivity.
Measured: Baseline assessment

Secondary outcomes (2)

Baseline Best-Ear Hearing Thresholds (2 kHz and 4 kHz)
Baseline best-ear hearing thresholds were summarized descriptively using the average minimum response levels (MRLs) at 2 kHz and 4 kHz. Lower values indicate better hearing sensitivity.
Measured: Baseline assessment
MacArthur-Bates Communicative Development Inventories (CDI): Words Produced Percentile Score
The MacArthur-Bates Communicative Development Inventories (CDI) Words Produced subscale is a parent-reported measure of expressive language development. Percentile scores range from 0 to 100, with higher percentile scores indicating better expressive language performance.
Measured: 20 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 201831 Aug 2022

First posted11 Apr 2017
Study start31 Aug 2018
Primary completion31 Aug 2022
Study completion31 Aug 2022

Why it stopped: Study sponsor closed trial due to slow enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cmv CongenitalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03107871
Sponsor's protocol ID: 90760
Other IDs: 1U01DC014706-01A1
Acronym: ValEAR
Status last verified: May 2026
First submitted: 13 Mar 2017
Last updated: 27 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Orb QT, Pesch M, Allen CM, Wilkes A, Ahmad I, Alfonso K, Antonio SM, Mithal LB, Brinkmeier JV, Carvalho D, Chan D, Cheng AG, Chi D, Cohen M, Discolo CM, Duran C, Germiller J, Gibson L, Grunstein E, Harrison G, Lee K, Hawley K, Kohlhoff S, Melvin A, MacArthur C, Nassar M, Neff L, Pecha P, Salvatore C, Schoem S, Virgin F, Saunders J, Schleiss M, Smith RJH, Sood S, Park AH. Congenital Cytomegalovirus Testing Outcomes From the ValEAR Trial. Otolaryngol Head Neck Surg. 2024 May;170(5):1430-1441. doi: 10.1002/ohn.670. Epub 2024 Feb 28.
PubMed 38415855

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Cytomegalovirus Infections, Primary Immune Deficiency Disorder
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Not yet recruitingPhase 1/2
Single Injection of rAAV9-CMV-hNAGLUop Gene for Patients With Mucopolysaccharidosis (MPS) IIIB
Sanfilippo Syndrome (MPS III)

All Cmv Congenital trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants: ValEAR Trial
ClinicalTrials.gov ID: NCT03107871
Acronym / sponsor ID: ValEAR / 90760
Conditions: Cmv Congenital, CMV, Congenital Cmv, SNHL, Sensorineural Hearing Loss
Keywords: valganciclovir
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study sponsor closed trial due to slow enrollment.
Enrolment: 10 participants (actual)
Lead sponsor: Albert ParkUniversity, hospital or other
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), Genentech, Inc.
Study start: 31 Aug 2018 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 11 Apr 2017 (actual)
Results: Posted 27 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Main Secondary Objectives:

To determine if valganciclovir treatment improves the following outcomes when compared to the control group:
The slope of best ear hearing thresholds over the 20 months after randomization.
The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for words produced at 20 months of age.
To evaluate safety measures based on all grade 3 or greater new adverse events designated by the NIAID Division of AIDS (DAIDS) toxicity tables.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: ValganciclovirValganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Arm B	Placebo comparator	Drug: Simple SyrupFlavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months

Who may qualify

Ages: 1 month to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ValganciclovirAlso: ValcyteValganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.	Drug	Arm A
Simple SyrupAlso: Sucrose WaterSimple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.	Drug	Arm B

Primary outcome

Baseline Total Ear Hearing Thresholds
Time frame: Baseline assessment
Baseline hearing thresholds were summarized descriptively using the average minimum response levels (MRLs) at 2 kHz and 4 kHz for each ear. Lower values indicate better hearing sensitivity.

2 secondary outcomes

Baseline Best-Ear Hearing Thresholds (2 kHz and 4 kHz)
Time frame: Baseline assessment
MacArthur-Bates Communicative Development Inventories (CDI): Words Produced Percentile Score
Time frame: 20 months of age

Results and safety

Results posted to the registry on 27 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Valganciclovir 16 mg/kg	6	5
Placebo	4	4

Primary outcome: Baseline Total Ear Hearing Thresholds

Time frame: Baseline assessment. Mean (Standard Deviation). Unit: decibels (dB)

Measure	Valganciclovir 16mg/kg n = 6	Placebo n = 4
Value	53.59 (15.93)	53.59 (15.93)

Population analysed: All randomized participants with baseline hearing assessments were included (6 valganciclovir, 4 placebo).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline (randomization) through last study follow-up visit, up to 20 months per participant.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valganciclovir 16 mg/kg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Placebo	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Limitations and caveats (from the sponsor): Study terminated early due to slow enrollment (N=10). Follow-up was incomplete and did not align with protocol timepoints (8, 14, 20 months), limiting longitudinal analyses. Data were collected but insufficient for protocol-defined endpoints; descriptive summaries are reported where possible. Prior submitted data were preliminary and updated after reconciliation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38415855Orb QT, Pesch M, Allen CM, Wilkes A, Ahmad I, Alfonso K, Antonio SM, Mithal LB, Brinkmeier JV, Carvalho D, Chan D, Cheng AG, Chi D, Cohen M, Discolo CM, Duran C, Germiller J, Gibson L, Grunstein E, Harrison G, Lee K, Hawley K, Kohlhoff S, Melvin A, MacArthur C, Nassar M, Neff L, Pecha P, Salvatore C, Schoem S, Virgin F, Saunders J, Schleiss M, Smith RJH, Sood S, Park AH. Congenital Cytomegalovirus Testing Outcomes From the ValEAR Trial. Otolaryngol Head Neck Surg. 2024 May;170(5):1430-1441. doi: 10.1002/ohn.670. Epub 2024 Feb 28.
Individual participant dataSharing planned: No

Related trials for Cmv Congenital

RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Cytomegalovirus Infections, Primary Immune Deficiency Disorder
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Not yet recruitingPhase 1/2
Single Injection of rAAV9-CMV-hNAGLUop Gene for Patients With Mucopolysaccharidosis (MPS) IIIB
Sanfilippo Syndrome (MPS III)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Albert Park, MD principal investigator

University of Utah

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Valganciclovir and Simple Syrup in people with Cmv Congenital and CMV, run by Albert Park at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Total Ear Hearing Thresholds (time frame: Baseline assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03107871, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.