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Trial record 7 of 102 for:    Valcyte

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

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ClinicalTrials.gov Identifier: NCT02606266
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Congenital Cytomegalovirus (CMV) Drug: Valganciclovir Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019


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 Name: 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



Primary Outcome Measures :
  1. Auditory threshold in db [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Canal function [ Time Frame: 6 months ]
    Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test)

  2. FBC (haemoglobin and leukocyte count) [ Time Frame: 6 weeks ]
  3. Serum valganciclovir concentrations [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606266


Contacts
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Contact: Natacha TEISSIER, MD-PhD +33140035367 natacha.teissier@aphp.fr
Contact: Thierry VAN DEN ABBEELE, MD-PhD +33140032449 thierry.van-den-abbeele@aphp.fr

Locations
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France
Robert Debré Hospital Recruiting
Paris, France, 75019
Contact: Natacha TEISSIER, MD-PhD    +33140035367    natacha.teissier@aphp.fr   
Contact: Thierry VAN DEN ABBEELE, MD-PhD    +33140032449    thierry.van-den-abbeele@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02606266     History of Changes
Other Study ID Numbers: P140310
2015-002232-41 ( EudraCT Number )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Valganciclovir
Cytomegalovirus Infections
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents