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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: Active Phase 2 study of Sensorineural Hearing Loss and CMV, sponsored by Albert Park.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2018-08-31 |
| Est. Completion | 2024-07 |
| Phase | Phase 2 |
What the registry record for NCT03107871 still lists
NCT03107871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 127-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (59% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Where NCT03107871's enrollment target sits among peer trials
52 7th of 13 higher than 7 of 13 other Sensorineural Hearing Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sensorineural Hearing Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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