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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2018-12-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Congenital Cytomegalovirus (CMV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Valganciclovir

Intervention Type DRUG

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension)

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No