Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants



Status:Enrolling by invitation
Conditions:Other Indications, Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:3/7/2019
Start Date:August 31, 2018
End Date:July 2024

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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 maximum worsening in
left or right ear hearing 8 months after randomization compared to untreated cCMV-infected
hearing impaired infants.

Main Secondary Objectives:

1. To determine if valganciclovir treatment improves the following outcomes when compared
to the control group:

1. The risk of a clinically significant worsening of hearing defined by occurrence of
cochlear implantation due to progressive hearing loss or a ≥ 10 dB (decibel)
increase in the minimum response level (MRL) at two or more audiometric test
frequencies (from among 1 kHz, 2 kHz, and 4kHz) in either the left or right ear or
a ≥ 15 dB increase at any of these frequencies in either the left or right ear
between baseline and 8 months post-randomization.

2. The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for
words produced at 22 months of age.

3. The change in the average MRL across the 2 and 4 kHz frequencies from baseline to 8
months post-randomization in the best-ear.

2. To evaluate safety measures based on all grade 3 or greater new adverse events
designated by the NIAID Division of AIDS (DAIDS) toxicity tables.

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.

Inclusion Criteria:

- Age greater than or equal to 1 month and less than or equal to 6 months at the time of
randomization; AND

- Greater than or equal to 37 weeks gestational age at birth; 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

- Potassium greater than 5.5 mEq/L; 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.
We found this trial at
30
sites
Shreveport, Louisiana 71130
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Boston, Massachusetts 02115
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chicago, Illinois 60611
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Evanston, IL
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Lebanon, New Hampshire 03756
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1000 North Oak Avenue
Marshfield, Wisconsin 54449
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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2450 Riverside Avenue
Minneapolis, Minnesota 55454
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269-01 76th Avenue
New York, New York 11040
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newark, Delaware 19718
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Palo Alto, California 94304
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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3655 Vista Avenue
Saint Louis, Missouri 63110
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Salt Lake City, Utah 84143
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San Francisco, California 94143
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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