Recombinant human a-glucosidase conjugated with multiple copies of synthetic bis-mannose-6-phosphate-tetra-mannose glycan (NEOGAA)

( DrugBank: - / KEGG DRUG: - )

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	16

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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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-000942-77-HU (EUCTR)	29/01/2019	04/12/2018	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies neoGAA and Alglucosidase Alf ...	A phase 3 randomized, multicenter, multinational, double-blinded study comparing the efficacy and sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 20.0;Level: LLT;Classification cod ...	Product Name: neoGAA Product Code: GZ402666 Other descriptive name: Recombinant human a-glucosidase co ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 3	Portugal;United States;Taiwan;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;D ...
2	EUCTR2016-000942-77-BG (EUCTR)	23/10/2018	24/07/2018	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies neoGAA and Alglucosidase Alf ...	A phase 3 randomized, multicenter, multinational, double-blinded study comparing the efficacy and sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 24.0;Level: LLT;Classification cod ...	Product Name: neoGAA Product Code: GZ402666 Other descriptive name: Recombinant human a-glucosidase co ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 3	United States;Portugal;Taiwan;Spain;Russian Federation;Colombia;Italy;Switzerland;France;Australia;D ...
3	EUCTR2016-000942-77-PT (EUCTR)	24/07/2018	12/04/2018	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies Avalglucosidase Alfa and Alg ...	A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 24.0;Level: LLT;Classification cod ...	Product Name: neoGAA or avalglucosidase alfa Product Code: GZ402666 INN or Proposed INN: neoGAA Other d ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	United States;Portugal;Taiwan;Spain;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Aus ...
4	EUCTR2016-003475-21-GB (EUCTR)	17/05/2017	03/01/2017	A Study to Assess Safety and Efficacy ofAvalglucosidase Alfa Administered Every Other Week in Pediat ...	An Open-label Ascending Dose Cohort Study to Assess the Safety, Pharmacokinetics, and Preliminary Ef ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 20.0;Level: LLT;Classification cod ...	Product Name: Avalglucosidase Alfa (NeoGAA) Product Code: GZ402666 INN or Proposed INN: Avalglucosidas ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	34	Phase 2	United States;France;Taiwan;Germany;Japan;United Kingdom
5	EUCTR2016-000942-77-NL (EUCTR)	21/03/2017	15/06/2016	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies neoGAA and Alglucosidase Alf ...	A phase 3 randomized, multicenter, multinational, double-blinded study comparing the efficacy and sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 20.0;Level: LLT;Classification cod ...	Product Name: neoGAA Product Code: GZ402666 INN or Proposed INN: NEO-GAA Other descriptive name: Recomb ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 3	United States;Portugal;Taiwan;Spain;Russian Federation;Colombia;Italy;Switzerland;France;Australia;D ...
6	EUCTR2016-000942-77-AT (EUCTR)	06/02/2017	31/10/2016	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies Avalglucosidase Alfa and Alg ...	A phase 3 randomized, multicenter, multinational, double-blinded study comparing the efficacy and sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 24.0;Level: LLT;Classification cod ...	Product Name: neoGAA or avalglucosidase alfa Product Code: GZ402666 Other descriptive name: Recombinan ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	Portugal;United States;Taiwan;Spain;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Net ...
7	EUCTR2016-000942-77-DE (EUCTR)	18/11/2016	27/06/2016	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies Avalglucosidase Alfa and Alg ...	A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 24.0;Level: LLT;Classification cod ...	Product Name: neoGAA or avalglucosidase alfa Product Code: GZ402666 Other descriptive name: Recombinan ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	Portugal;United States;Taiwan;Spain;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Net ...
8	EUCTR2016-000942-77-ES (EUCTR)	20/10/2016	22/06/2016	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies neoGAA and Alglucosidase Alf ...	A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 19.0;Level: LLT;Classification cod ...	Product Name: neoGAA Product Code: GZ402666 INN or Proposed INN: NeoGAA Other descriptive name: Recombi ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 3	United States;Taiwan;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Ita ...
9	EUCTR2016-000942-77-BE (EUCTR)	14/10/2016	01/07/2016	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies neoGAA and Alglucosidase Alf ...	A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 20.0;Level: LLT;Classification cod ...	Product Name: neoGAA Product Code: GZ402666 Other descriptive name: Recombinant human a-glucosidase co ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	United States;Portugal;Taiwan;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Denmark;Net ...
10	EUCTR2016-000942-77-CZ (EUCTR)	05/10/2016	27/06/2016	Study to Compare the Efficacy and Safety ofEnzyme Replacement Therapies neoGAA and Alglucosidase Alf ...	A phase 3 randomized, multicenter, multinational, double-blinded study comparing the efficacy and sa ...	Pompe disease (acid alpha-glucosidase deficiency) MedDRA version: 20.0;Level: LLT;Classification cod ...	Product Name: neoGAA Product Code: GZ402666 Other descriptive name: Recombinant human a-glucosidase co ...	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 3	United States;Portugal;Taiwan;Spain;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Aus ...

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