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A Non-interventional Post Authorization Study (PASS) to Evaluate Long-term Safety of Orfadin Treatment in Hypertyrosinemia Type 1 (HT-1) Patients in Standard Care

Trial Profile

A Non-interventional Post Authorization Study (PASS) to Evaluate Long-term Safety of Orfadin Treatment in Hypertyrosinemia Type 1 (HT-1) Patients in Standard Care

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 15 Jan 2020

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At a glance

  • Drugs Nitisinone (Primary)
  • Indications Tyrosinaemia type I
  • Focus Adverse reactions
  • Acronyms OPAL
  • Sponsors Swedish Orphan Biovitrum
  • Most Recent Events

    • 22 Oct 2019 Status changed from recruiting to completed.
    • 24 Jun 2018 Planned number of patients changed from 400 to 300.
    • 29 May 2017 Planned End Date changed from 1 Sep 2017 to 1 Sep 2019.
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