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ACTIVE NOT RECRUITING Phase 2

Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants

NCT03107871 · View on ClinicalTrials.gov ↗

Study Summary

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: 1. To determine if valganciclovir treatment improves the following outcomes when compared to the control group: 1. The slope of best ear hearing thresholds over the 20 months after randomization. 2. The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for words produced at 20 months of age. 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.

Interventions

  • DRUG Valganciclovir
  • DRUG Simple Syrup

Study Locations (20)

New York

  • SUNY Downstate Medical Center — Brooklyn
  • Weill Cornell Medicine — New York
  • Columbia University Medical Center — New York
  • Cohen Children's Medical Center — New York
  • The Children's Hospital at Montefiore — The Bronx

California

  • Lucile Packard Children's Hospital — Palo Alto
  • Rady Children's Hospital - San Diego — San Diego
  • UCSF Benioff Children's Hospital — San Francisco

Missouri

  • Children's Mercy Hospital — Kansas City
  • Saint Louis Universtiy — St Louis

Georgia

  • Children's Healthcare of Atlanta — Atlanta

Illinois

  • Lurie Children's Hospital — Chicago

Indiana

  • Indiana University School of Medicine — Indianapolis

Iowa

  • University of Iowa — Iowa City

Massachusetts

  • Massachusetts Eye and Ear — Boston

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2018-08-31
Est. Completion 2024-07
Phase Phase 2

Sponsor

Albert Park

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03107871

The ClinicalTrials.gov registry entry for NCT03107871 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Park, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Sensorineural Hearing Loss appearing as the primary indexed condition, and to 2 interventions — of which Valganciclovir is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03107871 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03107871 about?

NCT03107871 is a clinical study titled "Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants". 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-impai...

What is the current status of trial NCT03107871?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2018-08-31. Estimated completion is 2024-07.

What conditions does trial NCT03107871 study?

This clinical trial studies the following conditions: Sensorineural Hearing Loss, CMV, Cmv Congenital, Congenital Cmv, SNHL. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03107871?

The interventions under investigation include: Valganciclovir (DRUG), Simple Syrup (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03107871?

This trial is sponsored by Albert Park, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03107871 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial