Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1 (HT-1)
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
Sponsor: Swedish Orphan Biovitrum
Listed as NCT02323529, this PHASE3 trial focuses on Hereditary Tyrosinemia, Type I and remains completed. Sponsored by Swedish Orphan Biovitrum, it has been updated 6 times since 2014, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
▶ Show 1 earlier version
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Dec 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Swedish Orphan Biovitrum
For direct contact, visit the study record on ClinicalTrials.gov .