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

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Congenital Cytomegalovirus (CMV)

Treatments: Drug: Valganciclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT02606266

P140310

2015-002232-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Valganciclovir

Experimental group

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.

Treatment:

Drug: Valganciclovir

Control group

No Intervention group

Description:

Control group with standard care who do not receive the investigational medicinal product