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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Terminated
CT.gov ID
NCT02606266
Collaborator
(none)
1
Enrollment
1
Location
2
Arms
17
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
Actual Study Start Date :
Jul 11, 2017
Actual Primary Completion Date :
Jul 11, 2018
Actual Study Completion Date :
Dec 11, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Auditory threshold in db [6 months]

    Secondary Outcome Measures

    1. Canal function [6 months]

      Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test)

    2. FBC (haemoglobin and leukocyte count) [6 weeks]

    3. Serum valganciclovir concentrations [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert Debré Hospital Paris France 75019

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT02606266
    Other Study ID Numbers:
    • P140310
    • 2015-002232-41
    First Posted:
    Nov 17, 2015
    Last Update Posted:
    Nov 18, 2019
    Last Verified:
    Feb 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cytomegalovirus Infections
    Deafness
    Valganciclovir

    Study Results

    No Results Posted as of Nov 18, 2019