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Clinical trials for Oxalobacter

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    7 result(s) found for: Oxalobacter. Displaying page 1 of 1.
    EudraCT Number: 2018-003576-12 Sponsor Protocol Number: OC5-OL-02 Start Date*: 2019-01-23
    Sponsor Name:OxThera Intellectual Property AB
    Full Title: An open-label single-arm treatment extension study to evaluate the long-term efficacy and safety of Oxabact® for patients with primary hyperoxaluria who completed study OC5-DB-02
    Medical condition: Primary Hyperoxaluria (PH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020702 Hyperoxalemia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-015817-31 Sponsor Protocol Number: OC3-DB-02 Start Date*: 2009-12-01
    Sponsor Name:OxThera IP AB
    Full Title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, Study to Evaluate the Efficacy and Safety of Oxabact(TM) to Reduce Urinary Oxalate in Subjects with Primary Hyperoxaluria
    Medical condition: primary hyperoxaluria
    Disease: Version SOC Term Classification Code Term Level
    12.0 10020703 Hyperoxaluria LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005606-22 Sponsor Protocol Number: OC5-DB-01 Start Date*: 2013-07-10
    Sponsor Name:OxThera AB
    Full Title: A Phase 1/2, randomised, placebo-controlled, double-blind, multi-centre study to evaluate the efficacy and safety of OC5 to reduce urinary oxalate in subjects with primary hyperoxaluria
    Medical condition: Primary Hyperoxaluria (PH)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038359 - Renal and urinary disorders 10020703 Hyperoxaluria PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004368-74 Sponsor Protocol Number: OC5-OL-01 Start Date*: 2014-03-17
    Sponsor Name:OxThera Intellectual Property AB
    Full Title: A phase 2 open-label multi-centre study to evaluate the efficacy and safety of Oxabact® to reduce plasma oxalate in patients with primary hyperoxaluria who are on dialysis
    Medical condition: Primary Hyperoxaluria (PH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10020703 Hyperoxaluria PT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000684-33 Sponsor Protocol Number: OC5-DB-02 Start Date*: 2017-06-06
    Sponsor Name:OxThera Intellectual Property AB
    Full Title: A phase III double-blind, randomized study to evaluate the long-term efficacy and safety of Oxabact® in patients with primary hyperoxaluria
    Medical condition: Primary Hyperoxaluria (PH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020702 Hyperoxalemia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) ES (Completed) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-006187-30 Sponsor Protocol Number: OC3-OL-01 Start Date*: 2008-06-11
    Sponsor Name:OxThera, Inc.
    Full Title: An Open-label (OL) Extension Study evaluating the Long-Term Safety of OxabactTM in Subjects with Primary Hyperoxaluria (PH) who participated in the Double-Blind (DB) Efficacy Study
    Medical condition: primary hyperoxaluria
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020703 Hyperoxaluria LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002328-14 Sponsor Protocol Number: OC3-DB-01 Start Date*: 2008-01-10
    Sponsor Name:OxThera Inc.
    Full Title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, International Study to Evaluate the Efficacy and Safety of Oxabact(TM) to Reduce Urinary Oxalate in Subjects with Primary H...
    Medical condition: primary hyperoxaluria
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020703 Hyperoxaluria LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) NL (Completed) DE (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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