OLIPUDASE ALFA ( DrugBank: Olipudase 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	18

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	NCT05359276 (ClinicalTrials.gov)	June 10, 2022	28/4/2022	Data Analysis of Adult and Pediatric Participants With Acid Sphingomyelinase Deficiency (ASMD) on Ea ...	Acid Sphingomyelinase Deficiency (ASMD): Data Analysis of Adult and Pediatric Patients on Early Acce ...	Acid Sphingomyelinase Deficiency (ASMD)	Drug: Olipudase alfa	Sanofi	NULL	Recruiting	N/A	N/A	All	55		France
2	JPRN-jRCT2031210279	15/09/2021	27/08/2021	An open label interventional single-patient study to evaluate the safety of olipudase alfaenzyme rep ...	An open label interventional single-patient study to evaluate the safety of olipudase alfaenzyme rep ...	Acid sphingomyelinase deficiency	Drug: Olipudase alfa(GZ402665) Pharmaceutical form: lyophilized powder, Route of administration: Intr ...	Tanaka Tomoyuki	NULL	Not Recruiting	>= 20age old	Not applicable	Both	1	Phase 2-3	Japan
3	NCT04877132 (ClinicalTrials.gov)	July 21, 2021	3/5/2021	Compassionate Use Program for Olipudase AlfaEnzyme Replacement Therapy for Patients With Chronic Aci ...	Compassionate Use Program for Olipudase AlfaEnzyme Replacement Therapy for Patients With Chronic Aci ...	Sphingomyelin Lipidosis	Drug: olipudase alfa (GZ402665)	Sanofi	NULL	Approved for marketing	3 Years	N/A	All			NULL
4	EUCTR2013-000051-40-DE (EUCTR)	14/11/2018	01/10/2018	A Long-Term Study of Recombinant Human Acid Sphingomyelinase in Patients With Acid Sphingomyelinase ...	A Long-Term Study to Assess the Ongoing Safety and Efficacy of Olipudase Alfain Patients With Acid S ...	Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease) MedDRA version: 20.1;Le ...	Product Name: Olipudase alfa(rhASM) Product Code: GZ402665 INN or Proposed INN: Olipudase alfa Other de ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Phase 2	France;United States;Belgium;Brazil;Germany;United Kingdom;Italy
5	EUCTR2013-000051-40-IT (EUCTR)	19/08/2016	25/05/2016	A Long-Term Study of Recombinant Human Acid Sphingomyelinase in Patients With Acid Sphingomyelinase ...	A Long-Term Study to Assess the Ongoing Safety and Efficacy of Recombinant Human Acid Sphingomyelina ...	Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease) MedDRA version: 19.0;Le ...	Product Name: Olipudase alfa(rhASM) Product Code: GZ402665 INN or Proposed INN: Olipudase alfa Other de ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	17	Phase 2	France;United States;Brazil;Germany;United Kingdom;Italy
6	EUCTR2015-000371-26-IT (EUCTR)	08/03/2016	06/02/2018	Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfain Patients with Acid ...	A phase 2/3, multicenter, randomized, double-blinded, placebo-controlled, repeatdose, dose-compariso ...	Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease) MedDRA version: 20.1;Le ...	Product Name: OLIPUDASE ALFA Product Code: GZ402665 INN or Proposed INN: OLIPUDASE ALFA	GENZYME CORPORATION	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	35	Phase 2;Phase 3	Portugal;United States;Spain;Turkey;Chile;Israel;Italy;United Kingdom;France;Argentina;Brazil;Austra ...
7	EUCTR2015-000371-26-PT (EUCTR)	15/02/2016	08/09/2015	Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfain Patients with Acid ...	A Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Repeat Dose Study to Evalua ...	Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease) MedDRA version: 20.1;Le ...	Product Name: Olipudase alfa Product Code: GZ402665 INN or Proposed INN: Olipudase alfa Other descripti ...	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	36	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	Portugal;United States;Spain;Turkey;Chile;United Kingdom;Italy;France;Argentina;Brazil;Australia;Net ...
8	EUCTR2015-000371-26-NL (EUCTR)	19/01/2016	20/07/2015	Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfain Patients with Acid ...	A Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Repeat Dose Study to Evalua ...	Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease) MedDRA version: 20.1;Le ...	Product Name: Olipudase alfa Product Code: GZ402665 INN or Proposed INN: Olipudase alfa Other descripti ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36	Phase 2;Phase 3	Portugal;United States;Spain;Turkey;Chile;United Kingdom;Italy;France;Argentina;Brazil;Australia;Bul ...
9	EUCTR2015-000371-26-ES (EUCTR)	18/12/2015	05/10/2015	Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfain Patients with Acid ...	A phase 2/3, multicenter, randomized, double-blinded, placebo-controlled, repeatdose, dose-compariso ...	Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease) MedDRA version: 18.0;Le ...	Product Name: Olipudase alfa Product Code: GZ402665 INN or Proposed INN: Olipudase alfa Other descripti ...	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	35	Phase 2/3	Portugal;United States;Spain;Turkey;Chile;Israel;United Kingdom;Italy;France;Argentina;Brazil;Austra ...
10	NCT02004691 (ClinicalTrials.gov)	December 18, 2015	26/11/2013	Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfain Patients With Acid ...	A Phase 2/3, Multicenter, Randomized, Double-blinded, Placebo-controlled, Repeat-dose Study to Evalu ...	Sphingomyelin Lipidosis	Drug: placebo (saline);Drug: GZ402665	Genzyme, a Sanofi Company	NULL	Active, not recruiting	18 Years	N/A	All	36	Phase 2/Phase 3	United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Chile;France;Germany;Italy;Japan;Netherlan ...

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