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NCT03107871 · ClinicalTrials.gov registry record · Phase 2

Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants

A Phase 2 study of Sensorineural Hearing Loss and CMV, sponsored by Albert Park.

Active
Registry status
Phase 2
Development phase
52
Enrollment target
20
Study locations

NCT03107871 is a Phase 2 study of Sensorineural Hearing Loss and CMV that is active but no longer recruiting, run by Albert Park. The registered enrollment target is 52 participants, below the 127-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT03107871, a Phase 2 study of Sensorineural Hearing Loss and CMV, is active but no longer recruiting, sponsored by Albert Park.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
52 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Sensorineural Hearing Loss CMV Cmv Congenital Congenital Cmv SNHL

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, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 127-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (59% lower). The listed sponsor is Albert Park, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT03107871 reports 20 study locations spanning 13 distinct geographic areas - top geographies include New York, California, Missouri.

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.

What interventions are being tested in trial NCT03107871?

The interventions under investigation include: Valganciclovir (DRUG), Simple Syrup (DRUG).

Who is sponsoring clinical trial NCT03107871?

This trial is sponsored by Albert Park, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.