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Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

NCT01655212 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-06-18

No results posted yet for this study

Summary

The objective of the trial is to investigate whether early treatment with oral valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can prevent progression of hearing loss.

Conditions

  • Congenital Cytomegalovirus Infection
  • Sensorineural Hearing Loss

Interventions

DRUG

Valganciclovir

Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.

Sponsors & Collaborators

  • Stichting Nuts Ohra

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Dr. Ann C.T.M. Vossen

    lead OTHER

Principal Investigators

  • Ann CT Vossen, Dr. · Leiden University Medical Center

  • Anne Marie Oudesluys-Murphy, Prof. Dr. · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01655212 on ClinicalTrials.gov