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

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: Congenital Cytomegalovirus (CMV)
• Intervention / Treatment: Drug: Valganciclovir

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

Study Locations

• France
  • Paris, France, 75019
    • Robert Debré Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

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: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Otorhinolaryngologic Diseases; DNA Virus Infections; Ear Diseases; Sensation Disorders; Herpesviridae Infections; Hearing Disorders; Hearing Loss; Deafness; Cytomegalovirus Infections; Anti-Infective Agents; Antiviral Agents; Valganciclovir
• 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