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Clinical trials for ruconest

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
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    • 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   44379   clinical trials with a EudraCT protocol, of which   7391   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: ruconest. Displaying page 1 of 1.
    EudraCT Number: 2011-000987-92 Sponsor Protocol Number: C11209 Start Date*: 2011-09-26
    Sponsor Name:Pharming Technologies B.V.
    Full Title: Open-label, phase II, single arm study to evaluate the safety, immunogenicity, pharmacokinetics and efficacy of recombinant human C1 inhibitor for the treatment of acute attacks in pediatric patien...
    Medical condition: Attacks associated with hereditary angioedema (HAE) in pediatric population 2-13 years of age.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) SK (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2018-002904-14 Sponsor Protocol Number: C14101 Start Date*: 2019-06-03
    Sponsor Name:Pharming Technologies B.V.
    Full Title: A Phase I/II, Open Label, Proof of Concept Study to investigate Tolerability and Safety of Treatment with Recombinant Human C1 Inhibitor in Patients with Preeclampsia.
    Medical condition: Preeclampsia
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-002839-33 Sponsor Protocol Number: C1-3201 Start Date*: 2015-07-09
    Sponsor Name:Pharming Group NV
    Full Title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Efficacy and Safety of Recombinant Human C1 Inhibitor in the Prophylaxis of Angioedema ...
    Medical condition: Prophylaxis of Angioedema Attacks on Patients with Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10027664 Congenital and hereditary disorders NEC HLGT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-005083-34 Sponsor Protocol Number: CAPI2017NL10 Start Date*: 2017-08-23
    Sponsor Name:University Medical Center Utrecht
    Full Title: Conestat alfa as prophylactic treatment for idiopathic non-histaminergic acquired angioedema
    Medical condition: The medical condition to be investigated is idiopathic non-histaminergic angioedema (InH-AAE). This disease is characterized by recurrent episodes with swelling of the subcutis and mucous membranes...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000049-19 Sponsor Protocol Number: C1 1310 Start Date*: 2011-04-01
    Sponsor Name:Pharming Technologies B.V.
    Full Title: A Phase IIIb randomized, double-blind, placebo-controlled study with an open-label extension evaluating the efficacy, safety and immunogenicity of recombinant human C1 inhibitor for the treatment o...
    Medical condition: Treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).
    Disease: Version SOC Term Classification Code Term Level
    12.1 10019860 Hereditary angioedema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) IT (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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