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Open-label, Multicentre, Multiple-dose Trial to Evaluate Pharmacokinetics, Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Orfadin in Patients Diagnosed With Hereditary Tyrosinemia Type 1

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Trial Profile

Open-label, Multicentre, Multiple-dose Trial to Evaluate Pharmacokinetics, Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Orfadin in Patients Diagnosed With Hereditary Tyrosinemia Type 1

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Nitisinone (Primary)
  • Indications Tyrosinaemia type I
  • Focus Pharmacokinetics
  • Sponsors Swedish Orphan Biovitrum

    • Most Recent Events

    • 05 Sep 2017 According to a Swedish Orphan Biovitrum media release, Sobi has received approval from the U.S. Food and Drug Administration (FDA) for a reduced dosing frequency for Orfadin (nitisinone) from twice daily to once daily in patients 5 years of age and older.
    • 02 Feb 2017 According to Swedish Orphan Biovitrum media release, Sobi has received confirmation by the European Commission (EC) approving a reduced dosing frequency for Orfadin (nitisinone) from twice daily to once daily in people with hereditary tyrosinemia type 1 (HT-1) with a body weight >20 kg.
    • 10 Nov 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.

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