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Clinical trials for Arginase 1

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    9 result(s) found for: Arginase 1. Displaying page 1 of 1.
    EudraCT Number: 2022-003722-45 Sponsor Protocol Number: CAEB1102-305 Start Date*: 2023-04-17
    Sponsor Name:Aeglea Biotherapeutics, Inc.
    Full Title: A Phase 3 Open-Label Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects with Arginase 1 Deficiency
    Medical condition: Arginase I deficiency Hyperargininemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062695 Arginase deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004837-34 Sponsor Protocol Number: CAEB1102-300A Start Date*: 2019-06-18
    Sponsor Name:Aeglea Biotherapeutics, Inc.
    Full Title: PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and ...
    Medical condition: Arginase 1 Deficiency Hyperargininemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062695 Arginase deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) FR (Completed) GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003163-67 Sponsor Protocol Number: CAEB1102-102A Start Date*: 2019-01-15
    Sponsor Name:Aeglea Biotherapeutics, Inc.
    Full Title: An Open-label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of AEB1102 in Patients with Arginase I Deficiency
    Medical condition: Arginase 1 deficiency Hyperargininemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062695 Arginase deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003851-45 Sponsor Protocol Number: CAEB1102-101A Start Date*: 2018-03-14
    Sponsor Name:Aeglea Biotherapeutics, Inc.
    Full Title: A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102
    Medical condition: Arginase 1 deficiency Hyperargininemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062695 Arginase deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000650-11 Sponsor Protocol Number: HEP002 Start Date*: 2014-09-15
    Sponsor Name:Promethera Biosciences
    Full Title: A prospective, open label, multicountry, efficacy and safety study of several infusions of HepaStem in Urea Cycle Disorders pediatric patients.
    Medical condition: The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are seven disorders to be investigated: carbamoylphosphate synthetase I deficiency [CP...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002762-44 Sponsor Protocol Number: RG-16-040 Start Date*: 2018-05-01
    Sponsor Name:University of Birmingham
    Full Title: A phase I/II study evaluating the safety and activity of Pegylated recombinant human Arginase (BCT-100) in Relapsed/refractory cancers of Children and young adults
    Medical condition: Relpased/refractory paeditaric cancers: Leukaemias Sarcoma Neuroblastoma High grade glioma (brain cancers)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000830 Acute leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065443 Malignant glioma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10039494 Sarcoma NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-017091-25 Sponsor Protocol Number: P081110 Start Date*: 2010-07-09
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Quantification de la régression de l'albuminurie et de l'atteinte endothéliale dans une population de patients drépanocytaires homozygotes hyperfiltrants traités par inhibiteurs du système rénine-...
    Medical condition: Drépanocytose homozygote présentant une microalbuminurie associée à une hyperfiltration glomérulaire
    Disease: Version SOC Term Classification Code Term Level
    8.1 10040644 drépanocytose PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004074-28 Sponsor Protocol Number: UKHEP001 Start Date*: 2012-07-20
    Sponsor Name:Promethera Biosciences
    Full Title: A prospective, open label, multicenter, randomized, safety and preliminary efficacy study of one cycle of Promethera HepaStem® in Urea Cycle Disorders and Crigler-Najjar Syndrome patients
    Medical condition: Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The ur...
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004850 10021601 Inborn error of metabolism NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-006068-32 Sponsor Protocol Number: CDX110-04 Start Date*: 2012-07-04
    Sponsor Name:Celldex Therapeutics, Inc
    Full Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma ...
    Medical condition: Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) GR (Prematurely Ended) GB (Prematurely Ended) DE (Prematurely Ended) AT (Prematurely Ended) BE (Completed) ES (Prematurely Ended) NL (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
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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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