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 Patients With Hereditary Angioedema, From 2 up to and Including 13 Years of Age

Trial Profile

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 Patients With Hereditary Angioedema, From 2 up to and Including 13 Years of Age

Recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Oct 2017

At a glance

  • Drugs Conestat alfa (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Pharming Group NV
  • Most Recent Events

    • 10 Oct 2017 This study has been completed in Hungary (end date: 2017-07-17).
    • 30 Sep 2017 This study has been completed in Germany (end date: 2017-05-18).
    • 29 Sep 2017 According to a Pharming Group NV media release, this trial was designed in agreement with the European Medicines Agency (EMA) as part of a Paediatric Investigation Plan (PIP) to assess the pharmacokinetic, safety and efficacy profiles of RUCONEST at a dose of 50 IU/kg in paediatric HAE patients ages 2-13 years in support of a paediatric indication for treatment of HAE attacks.
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