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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.

Trial Profile

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.

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 Jul 2019

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At a glance

  • Drugs Conestat alfa (Primary)
  • Indications Preeclampsia
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors Pharming NV
  • Most Recent Events

    • 11 Jun 2019 According to a Pharming Group NV media release, The second (open label, proof of concept) part of the study (following approval by the ethics committees) is planned to include 30 patients in total recruited between two centres, of which one is in the Netherlands and one in Australia. The entire study is expected to last approximately one year, depending on the rate of recruitment and the early stage safety performance.
    • 11 Jun 2019 According to a Pharming Group NV media release, the combined results of both parts of the study are expected to be available in the third quarter of 2020.
    • 11 Jun 2019 Status changed from planning to recruiting according to a Pharming Group NV media release.
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