IDURSULFASE ( DrugBank: Idursulfase )

1 disease

ID	Disease name (Link within this page)	Number of trials
19	Lysosomal storage disease	30

19. Lysosomal storage disease

Clinical trials : 854 / Drugs : 716 - (DrugBank : 105) / Drug target genes : 70 - Drug target pathways : 191

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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	NCT05058391 (ClinicalTrials.gov)	April 30, 2022	24/9/2021	A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India	A Prospective, Multicenter, Single-arm, Open-label, Interventional Phase IV Study to Evaluate the Sa ...	Hunter Syndrome	Biological: Elaprase	Shire	NULL	Not yet recruiting	N/A	N/A	All	5	Phase 4	India
2	NCT04573023 (ClinicalTrials.gov)	February 14, 2022	17/9/2020	A Phase ? Study of JR-141 in Patients With Mucopolysaccharidosis II	A Phase ? Study of JR-141 in Patients With Mucopolysaccharidosis II	Mucopolysaccharidosis II	Drug: JR-141;Drug: Idursulfase;Drug: JR-141 or Idursulfase	JCR Pharmaceuticals Co., Ltd.	NULL	Recruiting	N/A	N/A	Male	50	Phase 3	United States
3	NCT02663024 (ClinicalTrials.gov)	December 2016	17/1/2016	Study of Idursulfase-beta (GC1111) in Hunter Syndrome	Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging Study to Evaluate the Pharmacokin ...	Mucopolysaccharidosis II	Biological: idursulfase beta;Biological: idursulfase	Green Cross Corporation	NULL	Not yet recruiting	5 Years	35 Years	Male	20	Phase 2	NULL
4	JPRN-JMA-IIA00350	29/07/2016	04/06/2018	Phase I/II clinical trial of idursulfase beta for mucopolysaccharidosis type II	Phase I/II clinical trial of idursulfase beta for mucopolysaccharidosis type II	Patients at the age between 6 months and 15 years with severe type mucopolysaccharidosis type II int ...	Intervention type:DRUG. Intervention1:BHP001, Dose form:INJECTION, Route of administration:OTHER.	Torayuki Okuyama	Haruo Shintaku	Completed	>=6 MONTHS	<15 YEARS	Male	6	Phase 1-2	Japan
5	EUCTR2014-004804-31-DE (EUCTR)	12/04/2016	06/08/2015	A long-term study on changes in height and weight of children with MPS II receiving Elaprase and who ...	A Long-Term, Open-Label, Multicenter, Phase IV Study to Assess Longitudinal Changes on Height and We ...	Hunter syndrome (Mucopolysaccharidosis II, [MPS II]);Therapeutic area: Diseases [C] - Congenital, He ...	Trade Name: Elaprase INN or Proposed INN: IDURSULFASE	Shire Human Genetic Therapies, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	20	Phase 4	United States;Serbia;Philippines;Saudi Arabia;Malaysia;Thailand;Costa Rica;Oman;Dominican Republic;G ...
6	NCT02412787 (ClinicalTrials.gov)	October 28, 2015	1/4/2015	Study of Long Term Safety and Clinical Outcomes of IdursulfaseIT and Elaprase Treatment in Pediatric ...	An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of In ...	Hunter Syndrome	Drug: Idursulfase-IT;Drug: Elaprase	Shire	NULL	Active, not recruiting	N/A	18 Years	Male	49	Phase 2/Phase 3	United States;Australia;Canada;France;Mexico;Spain;United Kingdom;Argentina;Colombia
7	EUCTR2014-004143-13-ES (EUCTR)	09/04/2015	09/02/2015	An extension peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and ...	An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of In ...	Hunter syndrome and cognitive impairment MedDRA version: 18.0;Level: PT;Classification code 10056889 ...	Product Name: Idursulfase-IT Product Code: HGT-2310 INN or Proposed INN: IDURSULFASE Other descriptive ...	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	42		United States;Mexico;Canada;Argentina;Spain;Colombia;United Kingdom
8	EUCTR2014-004143-13-GB (EUCTR)	19/03/2015	30/01/2015	An extension peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and ...	An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of In ...	Hunter syndrome and cognitive impairment MedDRA version: 20.1;Level: PT;Classification code 10056889 ...	Product Name: Idursulfase-IT Product Code: HGT-2310 INN or Proposed INN: IDURSULFASE Other descriptive ...	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	54	Phase 2;Phase 3	United States;France;Mexico;Canada;Argentina;Spain;Australia;Colombia;United Kingdom
9	NCT02055118 (ClinicalTrials.gov)	March 24, 2014	17/1/2014	Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients ...	A Controlled, Randomized, Two-arm, Open-label, Assessor-blinded, Multicenter Study of Intrathecal Id ...	Hunter Syndrome	Biological: idursulfase-IT;Other: No IT treatment	Shire	NULL	Completed	N/A	18 Years	Male	58	Phase 2/Phase 3	United States;Australia;Canada;France;Mexico;Spain;United Kingdom;Argentina;Colombia
10	EUCTR2013-002885-38-ES (EUCTR)	26/11/2013	08/10/2013	Peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and early cogniti ...	A Controlled,Randomized,Two-arm,Open-label,Assessor-blinded,Multicenter Study of Intrathecal Idursul ...	Treatment of Hunter syndrome and cognitive impairment MedDRA version: 16.0;Level: PT;Classification ...	Product Name: Idursulfase-IT Product Code: HGT-2310 INN or Proposed INN: IDURSULFASA Other descriptive ...	Shire HGT Inc	NULL	Not Recruiting			Female: no Male: yes	42	Phase 2;Phase 3	United States;Mexico;Argentina;Spain;United Kingdom

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