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Clinical trials for Congenital hearing loss

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    25 result(s) found for: Congenital hearing loss. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-001920-31 Sponsor Protocol Number: DMID11-0069 Start Date*: 2014-12-09
    Sponsor Name:University College London
    Full Title: A PHASE II RANDOMIZED AND CONTROLLED INVESTIGATION OF SIX WEEKS OF ORAL VALGANCICLOVIR THERAPY IN INFANTS AND CHILDREN WITH CONGENITAL CYTOMEGALOVIRUS INFECTION AND HEARING LOSS.
    Medical condition: Children born with congenital CMV infection may develop sequelae on follow-up, particularly sensorineural hearing loss. A recent systematic review reports that 13.5% of babies with congenital CMV ...
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004854 10040016 Sensorineural hearing loss LLT
    17.1 100000004854 10040017 Sensorineural hearing loss of combined types LLT
    17.1 100000004854 10040018 Sensorineural hearing loss, unspecified LLT
    17.1 100000004854 10040015 Sensorineural deafness LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-003068-30 Sponsor Protocol Number: CMV-MM-2 Start Date*: 2013-09-30
    Sponsor Name:LUMC
    Full Title: CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group
    Medical condition: Congenital cytomegalovirus infection. Sensorineural Hearingloss.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10010420 Congenital CMV infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-005378-44 Sponsor Protocol Number: CMV-MM-1 Start Date*: 2012-05-03
    Sponsor Name:LUMC
    Full Title: CONgenital Cmv: Efficacy of antiviral treatment in a Randomized controlled Trial
    Medical condition: Congenital cytomegalovirus infection. Sensorineural Hearingloss.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010420 Congenital CMV infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-000079-38 Sponsor Protocol Number: DB-OTO-001 Start Date*: 2023-05-09
    Sponsor Name:Decibel Therapeutics
    Full Title: A Phase 1/2, Open-Label, Multicenter Trial With a Single Ascending Dose Cohort With Unilateral Intracochlear Injection Followed by a Bilateral Injection Expansion Cohort to Evaluate the Safety, Tol...
    Medical condition: Congenital auditory neuropathy secondary to biallelic mutations of the otoferlin gene (hOTOF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10011874 Deaf LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004394-10 Sponsor Protocol Number: ACT16248 Start Date*: 2020-06-30
    Sponsor Name:Genzyme Corporation
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administe...
    Medical condition: Congenital, hereditary and neonatal diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10001843 Alport's syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-024300-10 Sponsor Protocol Number: EARLY_PRO-TECT_ALPORT Start Date*: 2012-02-27
    Sponsor Name:University Medical Center Göttingen
    Full Title: Early prospective therapy trial to delay renal failure in children with Alport syndrome.
    Medical condition: Alport's syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10001843 Alport's syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-001092-14 Sponsor Protocol Number: TIGEM5_USH Start Date*: 2023-10-12
    Sponsor Name:FONDAZIONE TELETHON
    Full Title: A phase I/II open label, dose escalation study of sub-retinal administration of a “mixture of two adeno-associated viral vectors of serotype 8 containing the 5 ´- half sequence of the human MYO7A ...
    Medical condition: Usher syndrome (USH) is characterized by the association of sensorineural hearing loss, Retinitis Pigmentosa (RP), and, in some cases, vestibular dysfunction. It is the most frequent cause of deaf-...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10063396 Usher's syndrome PT
    20.0 10010331 - Congenital, familial and genetic disorders 10063396 Usher's syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004594-43 Sponsor Protocol Number: ISTEM02 Start Date*: 2021-05-27
    Sponsor Name:CECS/I-Stem
    Full Title: AUDIOWOLF: A phase II, open-label, efficacy study of daily administration of sodium valproate in patients clinically affected by Wolfram syndrome due to monogenic mutation
    Medical condition: Wolfram syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10078338 Wolfram syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003490-15 Sponsor Protocol Number: CACZ885D2308 Start Date*: 2016-04-14
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: An Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1β Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated P...
    Medical condition: Cryopyrin-associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle-Wells Syndrome Neonatal Onset Multisystem Inflammatory Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10064570 Familial cold autoinflammatory syndrome PT
    19.0 10010331 - Congenital, familial and genetic disorders 10064574 NOMID LLT
    19.0 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    19.0 10010331 - Congenital, familial and genetic disorders 10064569 Muckle-Wells syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004909-27 Sponsor Protocol Number: DNLI-E-0002 Start Date*: 2020-07-22
    Sponsor Name:Denali Therapeutics Inc.
    Full Title: A PHASE 1/2, MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DNL310 IN PEDIATRIC SUBJECTS WITH HUNTER SYNDROME
    Medical condition: Hunter Syndrome (Mucopolysaccharidosis Type II [MPS II])
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10056917 Hunter's syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004058-11 Sponsor Protocol Number: RM-493-023 Start Date*: Information not available in EudraCT
    Sponsor Name:Rhythm Pharmaceuticals, Inc.
    Full Title: A Phase 3 trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström syndrome (AS) Patients with Moderate to Severe Obesity
    Medical condition: Obesity and hyperphagia in patients with Bardet-Biedl Syndrome or Alström syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2013-004478-80 Sponsor Protocol Number: Issue1 Start Date*: 2014-01-08
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: XENON AND COOLING THERAPY IN BABIES AT HIGH RISK OF BRAIN INJURY FOLLOWING POOR CONDITION AT BIRTH: A RANDOMISED OUTCOME STUDY (COOLXENON3 STUDY)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    16.1 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-004395-22 Sponsor Protocol Number: 402-C-1603 Start Date*: 2017-12-19
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome
    Medical condition: Alport Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10001843 Alport's syndrome PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004438-93 Sponsor Protocol Number: CT-ORZY-NPC-002 Start Date*: 2016-05-09
    Sponsor Name:Orphazyme A/S
    Full Title: Arimoclomol prospective double blind, randomised, placebo-controlled study in patients diagnosed with Niemann Pick disease type C
    Medical condition: Niemann Pick disease type C
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) IT (Completed) PL (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-004192-13 Sponsor Protocol Number: R3R01-ASFSGS-201 Start Date*: 2022-08-12
    Sponsor Name:River 3 Renal, Corporation
    Full Title: A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and...
    Medical condition: Alport Syndrome (AS) and Primary Steroid-Resistent Focal Segmental Glomerulosclerosis (FSGS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10001843 Alport's syndrome PT
    21.1 10038359 - Renal and urinary disorders 10067757 Focal segmental glomerulosclerosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-001429-32 Sponsor Protocol Number: CACZ885D2201 Start Date*: 2012-03-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, open label, 24-month treatment study to establish the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of canakinumab (anti-IL-1 beta antibody) in patients with...
    Medical condition: Neonatal onset multisystem inflammatory disease (abbreviated NOMID, also known as chronic infantile neurologic cutaneous and articular syndrome or CINCA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003666-41 Sponsor Protocol Number: MEC2020-0078 Start Date*: 2020-04-21
    Sponsor Name:Erasmus MC University Medical Center
    Full Title: Doxapram versus placebo in preterm newborns: an international double blinded multicenter randomized controlled trial.
    Medical condition: Preterm infants are at high risk of respiratory failure due to immaturity of the respiratory system. Respiratory failure is caused by a comprised lung function and impaired control of breathing. Co...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077323 Infantile mixed apnea LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000499-24 Sponsor Protocol Number: 200722 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
    Medical condition: preterm labour and improve neonatal health
    Disease: Version SOC Term Classification Code Term Level
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) ES (Completed) SE (Completed) DE (Completed) IT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-005194-37 Sponsor Protocol Number: CT-ORZY-NPC-001 Start Date*: 2015-10-19
    Sponsor Name:Orphazyme ApS
    Full Title: A prospective non-therapeutic study in patients diagnosed with Niemann-Pick disease type C in order to characterise the individual patient disease profile and historic signo-symptomatology progress...
    Medical condition: Niemann-Pick disease - type C
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-020797-41 Sponsor Protocol Number: NEMO1-08NR26 Start Date*: 2010-11-16
    Sponsor Name:Only for Children Pharmaceuticals
    Full Title: NEMO-1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.
    Medical condition: Neonatal Seizures in Hypoxic Ischemic Encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029205 - Nervous system disorders 10061197 Neonatal seizures LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) FI (Prematurely Ended) GB (Prematurely Ended) SE (Prematurely Ended) FR (Ongoing) NL (Prematurely Ended)
    Trial results: (No results available)
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