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Antiviral

Valganciclovir for Cytomegalovirus Congenital Infection

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 2, 4, 6, 8, 10, 12, months 4, 5 and 6.
Awards & highlights

Study Summary

This trial is testing whether valganciclovir can prevent hearing loss in newborns with asymptomatic CMV infection.

Eligible Conditions
  • Cytomegalovirus Congenital Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 2, 4, 6, 8, 10, 12, months 4, 5 and 6.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 2, 4, 6, 8, 10, 12, months 4, 5 and 6. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Participants Developing Sensorineural Hearing Loss (SNHL) in at Least One Ear Between Baseline and Study Month 6
Secondary outcome measures
Number of Ears of Mild Worsened Hearing
Number of Ears of Moderate Worsened Hearing
Number of Ears of Profound Worsened Hearing
+14 more

Side effects data

From 2015 Phase 4 trial • 40 Patients • NCT01509404
50%
Leukopenia
30%
Acute rejection
25%
BK infection
20%
CMV disease
15%
Candidiasis
5%
Thrombocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Valcyte Then Cytogam
Valcyte

Trial Design

1Treatment groups
Experimental Treatment
Group I: Confirmed congenital CMV without baseline SNHLExperimental Treatment1 Intervention
Valganciclovir 16 mg/kg/dose orally twice daily for four months, n=229
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valganciclovir
2019
Completed Phase 4
~2160

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,230 Total Patients Enrolled
1 Trials studying Cytomegalovirus Congenital Infection
12 Patients Enrolled for Cytomegalovirus Congenital Infection

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Asymptomatic Congenital CMV Treatment
2019. "Asymptomatic Congenital CMV Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03301415.
~1 spots leftby Apr 2025
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