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

Congenital Cytomegalovirus (CMV) Clinical Trial

— GANCIMVEAR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02606266
• Other study ID #: P140310
• Secondary ID: 2015-002232-41
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 11, 2017
• Est. completion date: December 11, 2018

Study information

• Verified date: February 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 11, 2018
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Cytomegalovirus (CMV)
• Cytomegalovirus Infections
• Deafness

Intervention

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.

Locations

Country	Name	City	State
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory threshold in db		6 months
Secondary	Canal function	Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test)	6 months
Secondary	FBC (haemoglobin and leukocyte count)		6 weeks
Secondary	Serum valganciclovir concentrations		6 weeks