Myozyme® (alglucosidase alfa) ( DrugBank: Alglucosidase alfa )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
256筋型糖原病2

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 153 - (DrugBank : 30) / 標的遺伝子数 : 31 - 標的パスウェイ数 : 134
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT00701701
(ClinicalTrials.gov)
December 14, 200817/6/2008Immune Tolerance Induction StudyAn Exploratory Study of the Safety and Efficacy of Immune Tolerance Induction (ITI) in Patients With Pompe Disease Who Have Previously Received MyozymePompe Disease;Glycogen Storage Disease Type II (GSD-II);Glycogenesis 2 Acid Maltase DeficiencyBiological: Myozyme® (alglucosidase alfa)Genzyme, a Sanofi CompanyNULLTerminated1 MonthN/AAll4Phase 4United States;Israel;Canada
2EUCTR2015-000582-31-Outside-EU/EEA
(EUCTR)
15/04/2015An Exploratory, Open-Label Study of the Safety and Efficacy of High Dose or High Dosing Frequency Myozyme® (alglucosidase alfa) Treatment in Patients with Pompe Disease Who Do Not Have an Optimal Response to the Standard Dose RegimenAn Exploratory, Open-Label Study of the Safety and Efficacy of High Dose or High Dosing Frequency Myozyme® (alglucosidase alfa) Treatment in Patients with Pompe Disease Who Do Not Have an Optimal Response to the Standard Dose Regimen Pompe disease (acid alpha-glucosidase deficiency)
MedDRA version: 17.1;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Myozyme 50 mg powder for concentrate for solution for infusion
INN or Proposed INN: ALGLUCOSIDASE ALFA
Genzyme Corporation IncNULLNAFemale: yes
Male: yes
14United States;Australia;Canada