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Clinical trials for Apolipoprotein B100

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   44365   clinical trials with a EudraCT protocol, of which   7389   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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    5 result(s) found for: Apolipoprotein B100. Displaying page 1 of 1.
    EudraCT Number: 2013-001517-32 Sponsor Protocol Number: K-877-201 Start Date*: 2013-10-02
    Sponsor Name:Kowa Research Europe
    Full Title: A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels
    Medical condition: dyslipidemia (eg hyperlipidaemia, hypertriglyceridaemia)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10020667 Hyperlipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) HU (Completed) DE (Completed) CZ (Completed) NL (Completed) DK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-000641-13 Sponsor Protocol Number: BIO89-100-221 Start Date*: 2020-09-30
    Sponsor Name:89bio, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects with Severe Hypertriglyceridemia
    Medical condition: Severe Hypertriglyceridemia (SHTG)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020870 Hypertriglyceridemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001518-39 Sponsor Protocol Number: K-877-303 Start Date*: 2017-01-16
    Sponsor Name:Kowa Research Institute, Inc.
    Full Title: A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Pa...
    Medical condition: Severe hypertriglyceridemia [fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) and mild or moderate renal impairment.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10020667 Hyperlipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) BG (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-003511-37 Sponsor Protocol Number: K-877-301 Start Date*: 2017-01-16
    Sponsor Name:Kowa Research Institute, Inc.
    Full Title: A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double­Blind, 12-Week Study With a 40-Week, Active-Controlled, Double­Blind Extension to Evaluate the Efficacy and Safety of K-877 in Adult ...
    Medical condition: severe hypertriglyceridemia [fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10020667 Hyperlipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-003373-18 Sponsor Protocol Number: ISIS681257-CS6 Start Date*: 2017-06-28
    Sponsor Name:Akcea Therapeutics, Inc.
    Full Title: A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 681257 Administered Subcutaneously to Patients with Hyperlipoproteinemia(a) and Established Cardiovascular Disease...
    Medical condition: Hyperlipoproteinemia(a) and Established Cardiovascular Disease (CVD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020668 Hyperlipoproteinemia LLT
    20.1 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) DK (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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