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A Multi-Centre, Multi-National, Open-Label, Dose Escalation Trial Evaluating Safety and Pharmacokinetics of Ascending Intravenous Doses of 40K Pegylated Recombinant FIX in Non-Bleeding Patients With Haemophilia B.

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Trial Profile

A Multi-Centre, Multi-National, Open-Label, Dose Escalation Trial Evaluating Safety and Pharmacokinetics of Ascending Intravenous Doses of 40K Pegylated Recombinant FIX in Non-Bleeding Patients With Haemophilia B.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Nonacog beta pegol (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms Paradigm 1
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 06 Jun 2017 According to a media release, the company expects to launch Refixia in the first Europe
    • 06 Jun 2017 According to a Novo Nordisk media release, based on the results from the paradigm clinical trial programme (see profiles 243891, 243935, 243947,243961 and 244049) and the positive opinion provided on 24 March 2017 by the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorisation for Refixia for the treatment of adolescents and adults with haemophilia B.
    • 31 May 2017 According to a Novo Nordisk media release, based on the results from the paradigm clinical trial programme (see profiles 243891, 243935, 243947,243961 and 244049) U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.

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