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 |
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Recruitment Status :
Terminated
(No eligibles patients)
First Posted : November 17, 2015
Last Update Posted : November 18, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Cytomegalovirus (CMV) | Drug: Valganciclovir | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1 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 |
| Actual Primary Completion Date : | July 11, 2018 |
| Actual Study Completion Date : | December 11, 2018 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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) |
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No Intervention: Control group
Control group with standard care who do not receive the investigational medicinal product
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- Auditory threshold in db [ Time Frame: 6 months ]
- Canal function [ Time Frame: 6 months ]Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test)
- FBC (haemoglobin and leukocyte count) [ Time Frame: 6 weeks ]
- 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 |
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
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
| France | |
| Robert Debré Hospital | |
| Paris, France, 75019 | |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT02606266 |
| Other Study ID Numbers: |
P140310 2015-002232-41 ( EudraCT Number ) |
| First Posted: | November 17, 2015 Key Record Dates |
| Last Update Posted: | November 18, 2019 |
| Last Verified: | February 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cytomegalovirus Infections Deafness Infections Hearing Loss Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders |
Neurologic Manifestations Nervous System Diseases Herpesviridae Infections DNA Virus Infections Virus Diseases Valganciclovir Antiviral Agents Anti-Infective Agents |