GA-GCB

( DrugBank: GA-GCB / KEGG DRUG: Velaglucerase alfa )

1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
19	ライソゾーム病	20

19. ライソゾーム病

臨床試験数 : 899 / 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182

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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	EUCTR2015-001578-17-IT (EUCTR)	18/07/2018	04/11/2020	An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Na ...	An Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect ofTreatment with Velaglucerase a ...	Gaucher Disease MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease ...	Trade Name: VPRIV - 400 U - POLVERE PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO(VETRO) ...	SHIRE HUMAN GENETIC THERAPIES, INC	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	United States;Spain;Israel;Germany;United Kingdom;Italy
2	EUCTR2015-001578-17-DE (EUCTR)	12/09/2016	22/12/2015	An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Na ...	An Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect ofTreatment with Velaglucerase a ...	Gaucher Disease MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease ...	Trade Name: VPRIV 400 Units powder for solution of infusion INN or Proposed INN: VELAGLUCERASE ALFA Ot ...	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	United States;Spain;Turkey;Israel;Germany;Italy;United Kingdom;India
3	EUCTR2015-001578-17-ES (EUCTR)	25/02/2016	13/01/2016	An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Na ...	An Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect of Treatment with Velaglucerase ...	Gaucher Disease MedDRA version: 18.1;Level: PT;Classification code 10075697;Term: Gaucher's disease ...	Trade Name: VPRIV 400 Units powder for solution of infusion INN or Proposed INN: VELAGLUCERASE ALFA Ot ...	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	United States;Canada;Spain;Israel;Germany;United Kingdom;Italy
4	EUCTR2015-001578-17-GB (EUCTR)	17/02/2016	21/12/2015	An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Na ...	An Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect ofTreatment with Velaglucerase a ...	Gaucher Disease MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease ...	Trade Name: VPRIV 400 Units powder for solution of infusion INN or Proposed INN: VELAGLUCERASE ALFA Ot ...	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	19	Phase 4	United States;Canada;Spain;Israel;Germany;United Kingdom
5	NCT00954460 (ClinicalTrials.gov)	October 2009	5/8/2009	Treatment Protocol of Velaglucerase Alfa for Patients With Type 1 Gaucher Disease	Multicenter Open-Label Treatment Protocol to Observe the Safety of Gene-Activated™ Human Glucocerebr ...	Gaucher Disease, Type 1	Drug: velaglucerase alfa	Shire	NULL	Approved for marketing	3 Years	N/A	All			United States
6	EUCTR2008-001965-27-ES (EUCTR)	23/12/2008	17/09/2008	Estudio de extensión abierto de terapia de sustitución enzimática con glucocerebrosidasa humana acti ...	Estudio de extensión abierto de terapia de sustitución enzimática con glucocerebrosidasa humana acti ...	Enfermedad de Gaucher de tipo IType I Gaucher disease MedDRA version: 9.1;Level: LLT;Classification ...	Product Name: Gene-Activated Human Glucocerebrosidase Product Code: GA-GCB INN or Proposed INN: velagl ...	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	102		Spain;United Kingdom
7	EUCTR2008-001965-27-GB (EUCTR)	29/10/2008	15/07/2008	An Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacemen ...	An Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacemen ...	Type I Gaucher disease MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's d ...	Product Name: Gene-Activated Human Glucocerebrosidase 400U/vial Product Code: GA-GCB INN or Proposed I ...	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 3	Spain;United Kingdom
8	NCT00635427 (ClinicalTrials.gov)	May 2008	6/3/2008	An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease	An Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacemen ...	Gaucher Disease, Type 1	Biological: VPRIV®	Shire	NULL	Completed	2 Years	N/A	All	95	Phase 3	United States;Argentina;India;Israel;Korea, Republic of;Paraguay;Poland;Russian Federation;Spain;Tun ...
9	EUCTR2006-006304-11-IT (EUCTR)	14/04/2008	04/08/2008	A Multicenter Open-Label Study of Gene-Activated Human Glucocerebrosidase (GA-GCB) Enzyme Replacemen ...	A Multicenter Open-Label Study of Gene-Activated Human Glucocerebrosidase (GA-GCB) Enzyme Replacemen ...	Patients with type 1 Gaucher disease who previously received imiglucerase MedDRA version: 9.1;Level: ...	Product Name: Gene-Activated Human Glucocerebrosidase Product Code: GA-GCB	SHIRE HUMAN GENETIC THERAPIES, INC.	NULL	Not Recruiting			Female: yes Male: yes	40		United Kingdom;Spain;Italy
10	EUCTR2007-002840-21-IT (EUCTR)	25/02/2008	15/04/2008	A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated Human Glucocerebrosi ...	A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated Human Glucocerebrosi ...	Patients with Gaucher disease of type 1 MedDRA version: 9.1;Level: LLT;Classification code 10018048; ...	Product Name: Gene Activated Human Glucocerebrosidase Product Code: GA-GCB Product Name: imiglucerasi I ...	SHIRE HUMAN GENETIC THERAPIES, INC.	NULL	Not Recruiting			Female: yes Male: yes	32		United Kingdom;Spain;Italy

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