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A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients

NCT06227429 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-12-23

No results posted yet for this study

Summary

This is a prospective, non-interventional, non-comparative, multicenter study to collect data on HT-1 patients in China treated with Nitisinone in a routine clinical setting. No tests or examinations are mandated in the study.

Conditions

  • Hereditary Tyrosinemia, Type I

Interventions

DRUG

Nitisinone

According to prescription

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Ioannis Kottakis, MD, PhD · Swedish Orphan Biovitrum

  • Xiaoping Luo, MD, PhD · Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

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 NCT06227429 on ClinicalTrials.gov