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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Apr 2020

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At a glance

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

    • 29 Apr 2020 According to a Pharming Group media release, European Commission has approved an extension in the indication of RUCONEST (conestat alfa) Marketing Authorisation to include the treatment of acute angioedema attacks in children with hereditary angioedema (HAE). This marketing authorisation expands the age range of Pharming lead product, RUCONEST.The European Commission decision allows children aged two years and older to be treated with RUCONEST for acute angioedema attacks.
    • 27 Mar 2020 According to a Pharming Group media release, the positive opinion is based on the data from this Phase II clinical trial in 20 children.This recommendation will allow children aged 2 years and older to be treated with RUCONEST for acute angioedema attacks. The European Commissions (EC) approval decision is expected in June 2020.
    • 27 Mar 2020 According to a Pharming Group media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended approval of RUCONEST (conestat alfa) for the treatment of acute angioedema attacks in children with hereditary angioedema (HAE). This marketing authorisation would expand the age range of RUCONEST which was previously approved for adults (since 2010) and adolescents (since 2016) in Europe.
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