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Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care

NCT02320084 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 315

Last updated 2024-09-19

No results posted yet for this study

Summary

The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

Conditions

  • Hereditary Tyrosinemia, Type I

Interventions

DRUG

Nitisinone

Nitisinone according to prescription

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Study Physician · Swedish Orphan Biovitrum

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02320084 on ClinicalTrials.gov