A Phase III 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 of Acute Attacks of Angioedema in Patients With HAE

Trial Profile

A Phase III 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 of Acute Attacks of Angioedema in Patients With HAE

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2017

At a glance

  • Drugs Conestat alfa (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Sponsors Pharming Group NV
  • Most Recent Events

    • 06 Mar 2017 Results of a pooled analysis of this and one more trial, presented at the 2017 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 26 Feb 2016 According to a Pharmaing Group NV media release, the CHMP has issued a positive opinion to the European Commission on Pharming's request to include the treatment of adolescents with HAE and to remove the requirements for rabbit IgE testing that forms part of the EU label for RUCONEST.
    • 15 Apr 2014 New trial record
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