Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance (GANCIMVEAR)

November 15, 2019 updated by: Assistance Publique - Hôpitaux de Paris

Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop deafness, some of whom will progress gradually to profound bilateral deafness.

No curative treatment is currently offered for this deterioration in hearing and management involves the use of a hearing aid or cochlear implant. Many studies describe the utility of antiviral treatment on the course of the deafness. These mostly involve neonates with multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or even improvement.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop deafness, some of whom will progress gradually to profound bilateral deafness.

No curative treatment is currently offered for this deterioration in hearing and management involves the use of a hearing aid or cochlear implant. Many studies describe the utility of antiviral treatment on the course of the deafness. These mostly involve neonates with multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or even improvement.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Robert Debre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children ≥ 6 months old and < 12 years old
  • Past history of proven congenital CMV infection
  • Auditory threshold of between 40 and 90 dB in at least 1 ear.

Exclusion Criteria:

  • Bilateral deafness > 90 dB
  • Contraindication to valganciclovir, particularly: Neutropenia with a known neutrophil count of <500/mm3, Hb<8g/dl or platelets< 25,000/mm3 (FBC to be confirmed before randomisation)
  • Past history of neutropenia on valganciclovir or allergy to the compound
  • Renal impairment with creatinine clearance of < 10 ml/min/1.72m2 (confirmation of renal function before randomisation) according to the Schwartz equation
  • Patients on other antiviral treatment
  • Gastrointestinal absorption problems
  • Patients participating in a biomedical research project on a medicinal product or similar product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Valganciclovir
Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension), at a dose of 16 mg/kg 2 times/day (max 900 mg/d) for 6 weeks.
Drug: Valganciclovir
Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension) at a dose of 16 mg/kg 2 times/day (max 900 mg/d) for 6 weeks.
Other Names:
  • Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension)
No Intervention: Control group
Control group with standard care who do not receive the investigational medicinal product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Auditory threshold in db
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canal function
Time Frame: 6 months
Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test)
6 months
FBC (haemoglobin and leukocyte count)
Time Frame: 6 weeks
6 weeks
Serum valganciclovir concentrations
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2017

Primary Completion (Actual)

July 11, 2018

Study Completion (Actual)

December 11, 2018

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 13, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P140310
  • 2015-002232-41 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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