Back to resultsEvaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance (GANCIMVEAR)
Primary Purpose
Congenital Cytomegalovirus (CMV)
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Valganciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Cytomegalovirus (CMV)
Eligibility Criteria
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
Sites / Locations
- Robert Debré Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Valganciclovir
Control group
Arm Description
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.
Control group with standard care who do not receive the investigational medicinal product
Outcomes
Primary Outcome Measures
Auditory threshold in db
Secondary Outcome Measures
Canal function
Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test)
FBC (haemoglobin and leukocyte count)
Serum valganciclovir concentrations
Full Information
NCT ID
NCT02606266
First Posted
November 5, 2015
Last Updated
November 15, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02606266
Brief Title
Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
Acronym
GANCIMVEAR
Official Title
Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
No eligibles patients
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cytomegalovirus (CMV)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valganciclovir
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group with standard care who do not receive the investigational medicinal product
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Other Intervention Name(s)
Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Auditory threshold in db
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Canal function
Description
Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test)
Time Frame
6 months
Title
FBC (haemoglobin and leukocyte count)
Time Frame
6 weeks
Title
Serum valganciclovir concentrations
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Robert Debré Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
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