Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-25 @ 8:20 PM
Study NCT ID:
NCT02606266
Status:
TERMINATED
Last Update Posted:
2019-11-18
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077562', 'term': 'Valganciclovir'}, {'id': 'D011208', 'term': 'Powders'}, {'id': 'D013535', 'term': 'Suspensions'}], 'ancestors': [{'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'No eligibles patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-13', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Auditory threshold in db', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Canal function', 'timeFrame': '6 months', 'description': 'Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography \\& HIT (Head Impulse Test)'}, {'measure': 'FBC (haemoglobin and leukocyte count)', 'timeFrame': '6 weeks'}, {'measure': 'Serum valganciclovir concentrations', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Cytomegalovirus (CMV)']}, 'descriptionModule': {'briefSummary': '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.\n\nNo 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.', 'detailedDescription': '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.\n\nNo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ≥ 6 months old and \\< 12 years old\n* Past history of proven congenital CMV infection\n* Auditory threshold of between 40 and 90 dB in at least 1 ear.\n\nExclusion Criteria:\n\n* Bilateral deafness \\> 90 dB\n* 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)\n* Past history of neutropenia on valganciclovir or allergy to the compound\n* Renal impairment with creatinine clearance of \\< 10 ml/min/1.72m2 (confirmation of renal function before randomisation) according to the Schwartz equation\n* Patients on other antiviral treatment\n* Gastrointestinal absorption problems\n* Patients participating in a biomedical research project on a medicinal product or similar product'}, 'identificationModule': {'nctId': 'NCT02606266', 'acronym': 'GANCIMVEAR', 'briefTitle': 'Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance', 'orgStudyIdInfo': {'id': 'P140310'}, 'secondaryIdInfos': [{'id': '2015-002232-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Valganciclovir', '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.', 'interventionNames': ['Drug: Valganciclovir']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group with standard care who do not receive the investigational medicinal product'}], 'interventions': [{'name': 'Valganciclovir', 'type': 'DRUG', 'otherNames': ['Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension)'], '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.', 'armGroupLabels': ['Valganciclovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Robert Debré Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}