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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2017

At a glance

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

    • 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.
    • 12 Aug 2015 Planned End Date changed from 1 Aug 2015 to 1 Dec 2015, according to ClinicalTrials.gov record.
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