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Clinical trials for Volanesorsen

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   44334   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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    4 result(s) found for: Volanesorsen. Displaying page 1 of 1.
    EudraCT Number: 2021-003635-29 Sponsor Protocol Number: ISIS678354-CS7 Start Date*: 2022-06-15
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: An Open-Label Safety Study of AKCEA-APOCIII-LRX Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS) Previously Treated with Volanesorsen (ISIS 304801)
    Medical condition: Familial Chylomicronemia Syndrome
    Disease: Version SOC Term Classification Code Term Level
    24.1 100000004850 10085051 Familial chylomicronemia syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003755-21 Sponsor Protocol Number: ISIS304801-CS7 Start Date*: 2016-06-06
    Sponsor Name:Akcea Therapeutics
    Full Title: An Open-Label Study of Volanesorsen Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS)
    Medical condition: Familial Chylomicronemia Syndrome (FCS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10017339 Fredrickson Type I lipidaemia LLT
    20.0 100000004850 10060593 Fredrickson Type I lipidemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) ES (Completed) DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002997-28 Sponsor Protocol Number: ISIS304801-CS20 Start Date*: 2021-03-17
    Sponsor Name:Akcea Therapeutics, Inc.
    Full Title: An Open-Label Study of Volanesorsen (ISIS 304801) Administered Subcutaneously to Pediatric Patients with Familial Chylomicronemia Syndrome (FCS)
    Medical condition: Familial Chylomicronemia Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020606 Hyperchylomicronaemia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000493-35 Sponsor Protocol Number: ISIS-304801-CS17 Start Date*: 2016-02-17
    Sponsor Name:Akcea Therapeutics, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy
    Medical condition: Partial lipodystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10053857 Partial lipodystrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) PT (Prematurely Ended) ES (Completed) NL (Completed) GR (Prematurely Ended) IT (Completed)
    Trial results: View results
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    Query did not match any studies.
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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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