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 241. 高チロシン血症1型 [臨床試験数:11,薬物数:6(DrugBank:1),標的遺伝子数:1,標的パスウェイ数:4] 

Searched query = "Hypertyrosinemia type I", "Tyrosinemia type I", "Tyrosinemia I", "Hereditary tyrosinemia, Type I"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04113772November 1, 201914 October 2019Bio Equivalency 20 Mgm Orfadin and 20 Mgm of NitisonineOrfadin and Nitinosine StudyHereditary Tyrosinemia, Type IDrug: Nitisinone;Drug: OrfadinSutphin DrugsNot recruiting18 Years50 YearsAll4N/AIndia
2NCT02750345March 201616 December 2017Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)A Three-Period Crossover Study to Determine the Bioequivalence of Two Oral Formulations Containing Nitisinone 10 mg Compared to Reference Formulation Orfadin In Healthy Subjects Under Fasting ConditionsHereditary Tyrosinemia, Type IDrug: Nitisinone;Drug: Nitisinone Baked Tablet;Drug: OrfadinCycle Pharmaceuticals Ltd.ParexelNot recruiting18 Years55 YearsAll24Phase 1South Africa
3NCT02750332November 201516 December 2017Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)A Single Center, Single-Dose, Open-Label, Randomized Study to Compare the Bioavailability of an Oral Test Formulation Containing Nitisinone 10 mg in at Least 16 Healthy Male and Female Subjects Under Fasting and Fed ConditionsHereditary Tyrosinemia, Type IDrug: NitisinoneCycle Pharmaceuticals Ltd.ParexelNot recruiting18 Years55 YearsAll20Phase 1South Africa
4NCT02750709October 201516 December 2017Bioequivalence Study of Two Nitisinone Formulations Compared to OrfadinA Single Center, Single-Dose, Open-Label, Laboratory-Blind, Randomized, Three-Period Crossover Study to Determine the Bioequivalence of Two Oral Formulations Containing of Nitisinone 10 mg Compared to the Reference Formulation Orfadin 10 mg in at Least 18 Healthy Male and Female Subjects Under Fasting ConditionsHereditary Tyrosinemia, Type IDrug: Nitisinone;Drug: Nitisinone 10 mg Tablet High Compritol;Drug: OrfadinCycle Pharmaceuticals Ltd.ParexelNot recruiting18 Years55 YearsAll24Phase 1South Africa
5NCT02323529December 201423 November 2015Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1Open-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 1Hereditary Tyrosinemia, Type IDrug: NitisinoneSwedish Orphan BiovitrumNot recruitingN/AN/ABoth18Phase 3Belgium;Denmark;France;Germany;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-004132-29-SE15/10/201414 December 2015An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, efficacy and safety of once daily dosing compared to twice daily dosing of Orfadin in patients diagnosed with hereditary tyrosinemia type 1An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, efficacy and safety of once daily dosing compared to twice daily dosing of Orfadin in patients diagnosed with hereditary tyrosinemia type 1hereditary tyrosinemia type 1
MedDRA version: 17.1 Level: LLT Classification code 10069462 Term: Tyrosinemia type I System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Orfadin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NITISINONE
CAS Number: 104206-65-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 2-10
Swedish Orphan Biovitrum AB (Publ)Not RecruitingFemale: yes
Male: yes
20Belgium;Denmark;Sweden
7NCT02320084September 201311 November 2019Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical CareA Non-interventional Post Authorization Study (PASS) to Evaluate Long-term Safety of Orfadin Treatment in Hypertyrosinemia Type 1 (HT-1) Patients in Standard CareHereditary Tyrosinemia, Type IDrug: NitisinoneSwedish Orphan BiovitrumNot recruitingN/AN/AAll315Phase 1Austria;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom;Croatia;Czech Republic;Greece;Kosovo;Lithuania;Macedonia, The Former Yugoslav Republic of;Romania;Slovakia;Switzerland
8EUCTR2012-002286-36-DE19/11/201220 May 2013Taste and palatability of Orfadin suspension.Taste and palatability of Orfadin suspension. An open, non-controlled 3-day study in pediatric patients with hereditary tyrosinemia type 1 treated with Orfadin.Hereditary tyrosinemia type 1 (HT-1)
MedDRA version: 14.1 Level: LLT Classification code 10069459 Term: Tyrosinaemia type I System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Orfadin oral suspension 4mg/ml
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Nitisinone
CAS Number: 104206-65-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Swedish Orphan Biovitrum ABNot RecruitingFemale: yes
Male: yes
18Germany;United Kingdom
9NCT01734889October 201219 October 2017Taste and Palatability of Orfadin SuspensionTaste and Palatability of Orfadin Suspension. An Open, Non-controlled 3 Day Study in Pediatric Patients With Hereditary Tyrosinemia Type 1 Treated With Orfadin.Hereditary Tyrosinemia, Type IDrug: NitisinoneSwedish Orphan BiovitrumNot recruiting1 Month17 YearsAll18Phase 1France;Germany;United Kingdom
10NCT00004443October 19987 April 2015Study of NTBC for Tyrosinemia ITyrosinemia IDrug: NTBCUniversity of WashingtonNot recruitingN/A17 YearsBoth20N/AUnited States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT00004333November 199419 February 2015Phase II Study of the Enzyme Inhibitor NTBC for Tyrosinemia Type ITyrosinemia, Type IDrug: NTBCNational Center for Research Resources (NCRR)University of MichiganNot recruitingN/AN/ABothPhase 2

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