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: 21 Oct 2016

At a glance

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

    • 07 Jun 2017 Biomarkers information updated
    • 14 Oct 2016 Planned End Date changed from 1 Dec 2016 to 1 Dec 2017.
    • 14 Oct 2016 Planned primary completion date changed from 1 Dec 2016 to 1 Dec 2017.
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