NCT02323529 - Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions

Hereditary Tyrosinemia, Type I

Interventions

DRUG

Nitisinone

All patients in the study will first be put on twice daily dosing of nitisinone for 4 weeks. This will then be followed by once daily dosing of nitisinone for 4 weeks. The dose of nitisinone in the study will be the same as the one prescribed at completed screening visit. Dose will be 1-2 mg/kg body weight.

Trial Locations (6)

Unknown

Swedish Orphan Biovitrum Investigational Site, Brussels

Swedish Orphan Biovitrum Investigational Site, Copenhagen

Swedish Orphan Biovitrum Investigational Site, Lyon

Swedish Orphan Biovitrum Investigational Site, Giessen

Swedish Orphan Biovitrum Investigational Site, Reutlingen

Swedish Orphan Biovitrum Investigational site, Gothenburg