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Clinical trials for sids

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44132   clinical trials with a EudraCT protocol, of which   7324   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    11 result(s) found for: sids. Displaying page 1 of 1.
    EudraCT Number: 2015-002094-38 Sponsor Protocol Number: 0584 Start Date*: 2016-12-29
    Sponsor Name:University of Leicester
    Full Title: The Effect of an SGLT2 inhibitor on Glucose Flux, Lipolysis and Ketogenesis following insulin withdrawal in people with absolute or relative endogenous insulin deficiency
    Medical condition: Type 1 and Type 3c diabetes
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2004-002743-27 Sponsor Protocol Number: TKT024EXT Start Date*: 2004-12-23
    Sponsor Name:Shire Human Genetic Therapies INC.
    Full Title: An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy
    Medical condition: Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10056889 PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) GB (Completed) SE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-004143-13 Sponsor Protocol Number: SHP-609-302 Start Date*: 2015-03-19
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction with Elaprase® in Patients with Hunter Syndrome...
    Medical condition: Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    20.0 10010331 - Congenital, familial and genetic disorders 10056917 Hunter's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000212-25 Sponsor Protocol Number: HGT-HIT-046 Start Date*: 2012-01-05
    Sponsor Name:Shire HGT Inc
    Full Title: An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction with Intravenous Elaprase® in Pediatric Pati...
    Medical condition: Treatment of Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2007-006044-22 Sponsor Protocol Number: HGT-ELA-038 Start Date*: Information not available in EudraCT
    Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire HGT)
    Full Title: A Multi-Center, Open-Label Study Evaluating Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Enzyme Replacement Therapy
    Medical condition: Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    10.1 10056889 PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-020048-36 Sponsor Protocol Number: HGT-HIT-045 Start Date*: 2011-01-31
    Sponsor Name:Shire HGT, Inc
    Full Title: A Phase I/II, Randomized, Safety and Ascending Dose Ranging Study of Intrathecal Idursulfase-IT administered in conjunction with intravenous Elaprase in Pediatric Patients with Hunter Syndrome and ...
    Medical condition: Treatment of Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-003200-14 Sponsor Protocol Number: JR-141-GS31 Start Date*: 2022-05-16
    Sponsor Name:JCR Pharmaceuticals Co., Ltd.
    Full Title: A Phase III study of JR-141 in Mucopolysaccharidosis type II (Hunter Syndrome) patients.
    Medical condition: Mucopolysaccharidosis type II
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002885-38 Sponsor Protocol Number: HGT-HIT-094 Start Date*: 2013-10-22
    Sponsor Name:Shire HGT Inc
    Full Title: A Controlled,Randomized,Two-arm,Open-label,Assessor-blinded,Multicenter Study of Intrathecal Idursulfase-IT Administered in Conjunction with Elaprase® in Pediatric Patients with Hunter Syndrome and...
    Medical condition: Long-term treatment of Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-001453-26 Sponsor Protocol Number: MPS protocol 08-06-07 Start Date*: 2007-07-02
    Sponsor Name:
    Full Title: Natural course, effects of enzyme therapy and health economic aspects in patients with mucopolysaccharidosis type I, II and VI. Long-term folloe-up of untreated patients and patients receiving com...
    Medical condition: Mucopolysaccharidosis type I, II and VI.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10028095 Mucopolysaccharidosis IV LLT
    12.0 10056886 Mucopolysaccharidosis I LLT
    12.0 10056889 Mucopolysaccharidosis II PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005200-35 Sponsor Protocol Number: DNLI-E-0007 Start Date*: Information not available in EudraCT
    Sponsor Name:Denali Therapeutics Inc.
    Full Title: A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tividenofusp (DNL310) vs Idursulfase in Pediatric and Young Adults Participants With Neuronopathic...
    Medical condition: Mucopolysaccharidosis Type II [MPS II]
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing) NL (Ongoing) ES (Ongoing) BE (Ongoing) FR (Ongoing) CZ (Ongoing) SE (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    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 (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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