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

NCT02606266 | Terminated Phase 2

• 2 other identifiers: P1403102015-002232-41
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Cytomegalovirus (CMV)

Outcome Measures

Primary Outcomes (1)

• Auditory threshold in db

  6 months

Secondary Outcomes (3)

• Canal function

  6 months

• FBC (haemoglobin and leukocyte count)

  6 weeks

• Serum valganciclovir concentrations

  6 weeks

Study Arms (2)

Valganciclovir

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Valganciclovir 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.

Also known as: Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension)

Valganciclovir

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir; Powders; Suspensions

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Colloids; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 17, 2015
• Study Start: July 11, 2017
• Primary Completion: July 11, 2018
• Study Completion: December 11, 2018
• Last Updated: November 18, 2019

Record last verified: 2018-02

Locations

FR (1)