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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.

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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: 26 Oct 2022

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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

    • 23 Oct 2022 According to the EudraCT record the study has been Prematurely Ended in Netherlands
    • 04 Mar 2020 According to a Pharming Group NV media release, a small safety study expected to read out headline data in 2020 and a larger Phase II proof of concept study which will follow on from a successful outcome of the first part.
    • 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.
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