Recombinant human acid alfa-glucosidase (ATB200) ( DrugBank: - )


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1

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 133 - (DrugBank : 29) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 105
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agemin
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agemax
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PhaseCountries
1JPRN-JapicCTI-194887
17/9/201926/07/2019ATB200/AT2221phase3 double blind randomized studyA phase 3 double-blind randomized study to assess the efficacy and safety of intravenous ATB200 co-administered with oral AT2221 in adult subjects with late- onset pompe disease compared with alglucosidase alfa/placebo Pompe diseaseIntervention name : Recombinant human acid alfa-glucosidase (ATB200)
INN of the intervention : Recombinant human acid alfa-glucosidase
Dosage And administration of the intervention : 20 mg/kg IV infusion over a 4-hour duration 1 hour after AT2221(Miglustat) administration every 2 weeks
Intervention name : Miglustat (AT2221)
INN of the intervention : Miglustat
Dosage And administration of the intervention : Subjects weighing >= 50 kg, 260mg (4 oral capsules of AT2221) 1hour prior to ATB200 infusion every 2 weeks. Subjects weighing >= 40 kg to < 50 kg, 195 mg (3 oral capsules) 1 hour prior to ATB200 infusion every 2 weeks.
Control intervention name : Alglucosidase Alfa (Genetical Recombination)
INN of the control intervention : Alglucosidase Alfa (Genetical Recombination)
Dosage And administration of the control intervention : 20 mg/kg IV infusion over a 4-hour duration 1 hour after placebo administration every 2 weeks
Control intervention name : Plecebo
INN of the control intervention : -
Dosage And administration of the control intervention : -
Amicus Therapeutics, Inc./CMIC Co., Ltd.NULLcomplete18BOTH110Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania