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Clinical trial

Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1 (HT-1)

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Last updated:1st Dec 2014
Identifier: NCT02323529

The purpose of this study is to look at the steady-state serum concentrations of nitisinone when switching from twice daily and once daily dosing.


Study Type: Interventional
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Enrollment: 18
Study Start Date: December 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Nitisinone treatment group

Category Value
Date last updated at source 2015-11-11
Study type(s) Interventional
Expected enrolment 18
Study start date 2014-12-01
Estimated primary completion date 2015-09-01

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