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Trial record 2 of 20 for:    CMV and Utah

Randomized Controlled Trial of Valganciclovir for Asymptomatic Cytomegalovirus Infected Hearing Impaired Infants (ValEAR)

This study is not yet open for participant recruitment.
Verified September 2017 by Albert Park, University of Utah
Sponsor:
ClinicalTrials.gov Identifier:
NCT03107871
First Posted: April 11, 2017
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Genentech, Inc.
Information provided by (Responsible Party):
Albert Park, University of Utah
  Purpose

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.

Aim 1: Test the hypothesis that asymptomatic CMV-infected hearing impaired infants treated with antiviral valganciclovir will have better hearing and language outcomes compared with untreated CMV-infected hearing impaired infants.

Aim 2: Evaluate the safety of antiviral valganciclovir therapy for asymptomatic CMV-infected hearing impaired infants.

Aim 3: Evaluate the pharmacokinetics (pK) of valganciclovir using pharmacometrics modeling to develop a population pK model.


Condition Intervention Phase
Cmv Congenital CMV Congenital Cmv SNHL Sensorineural Hearing Loss Drug: Valganciclovir Drug: Simple Syrup Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Placebo and active drug will be dispensed in identical amber bottles with identical labeling.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Valganciclovir for Asymptomatic Cytomegalovirus Infected Hearing Impaired Infants: ValEAR Trial

Resource links provided by NLM:


Further study details as provided by Albert Park, University of Utah:

Primary Outcome Measures:
  • Best-Ear Hearing Score [ Time Frame: Assessed at 12 months of age ]
    The primary outcome is defined as the change from baseline to age 12 months in the best-ear hearing score in the hearing score corresponding to the best ear at each time point.


Secondary Outcome Measures:
  • Substantial Best-Ear Worsening Hearing Composite Outcome [ Time Frame: Assessed at 12 and 24 months of age ]
    A clinically significant worsening hearing in the best ear will be defined as the occurrence of a) Cochlear implantation or b) a 20 decibel (dB) or greater increase in the best ear minimum response level (MRL) for at least one of the frequencies 1 kilohertz (kHz), 2 kHz, or 4 kHz but no decrease in the best ear MRL at any of these three frequencies.

  • Communicative Development Outcome [ Time Frame: Assessed at 12 and 24 months of age ]
    Communicative development outcome is the MacArthur-Bates Communicative Development Inventory (CDI) summary score. The summary score is defined by averaging the percentile scores of the four domains of this instrument.


Estimated Enrollment: 108
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Valganciclovir 16 mg/kg PO twice daily (BID) x 6 months
Drug: Valganciclovir
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.
Other Name: Valcyte
Placebo Comparator: Arm B
Flavored Simple Syrup, volume equivalent to active arm dose, PO BID x 6 months
Drug: Simple Syrup
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age less than 6 months at the time of randomization; AND
  • Less 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
  • Failed hearing screen, with confirmed sensorineural hearing loss (SNHL) by auditory brainstem response (ABR) testing.

Exclusion Criteria:

  • Imminent demise; OR
  • Lack of commitment to aggressive care; OR
  • Significant gastrointestinal disorders (e.g., eosinophilic esophagitis, ulcerative colitis); OR
  • Significant hematologic disorders (e.g., hemophilia, leukemia, sickle cell anemia); 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
  • Other known cause contributing to SNHL (e.g., meningitis, aminoglycoside ototoxicity); OR
  • Bilateral profound SNHL or auditory neuropathy spectrum disorder; OR
  • Evidence of intracranial calcification; OR
  • Evidence of hydrocephalus; OR
  • Microcephaly; OR
  • Presence of petechiae; OR
  • Intrauterine growth retardation; OR
  • Hepatitis; OR
  • Parent or guardian unable to speak English or Spanish; OR
  • Patient unable to attend follow-up hearing and developmental assessment at 12 months of age.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107871


Contacts
Contact: Stephanie Bisping, BSN 801-587-7758 stephanie.bisping@hsc.utah.edu
Contact: Kaitlin Cooley 801-213-4055 kaitlin.cooley@hsc.utah.edu

  Show 30 Study Locations
Sponsors and Collaborators
Albert Park
National Institute on Deafness and Other Communication Disorders (NIDCD)
Genentech, Inc.
Investigators
Principal Investigator: Albert Park, MD University of Utah
  More Information

Responsible Party: Albert Park, Chief Peds Otolaryngology, University of Utah
ClinicalTrials.gov Identifier: NCT03107871     History of Changes
Other Study ID Numbers: 90760
First Submitted: March 13, 2017
First Posted: April 11, 2017
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Albert Park, University of Utah:
valganciclovir

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents