Idursulfase

BIOLOGICAL7 trials

Sponsors

Shire, GlaxoSmithKline, Green Cross Corporation, JCR Pharmaceuticals Co., Ltd., Denali Therapeutics Inc.

Conditions

Hunter SyndromeMPS IIMucopolysaccharidosis IIMucopolysaccharidosis II (MPS II)

Phase 2

Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase

CompletedNCT00630747

ShireHunter Syndrome, Mucopolysaccharidosis II (MPS II)

Start: 2004-09-13End: 2008-01-31Updated: 2021-06-10

Study of Idursulfase-beta (GC1111) in Hunter Syndrome

Green Cross CorporationMucopolysaccharidosis II

Start: 2016-12-31End: 2020-06-30Target: 20Updated: 2016-01-26

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

Active, not recruitingNCT05371613

Denali Therapeutics Inc.Mucopolysaccharidosis II

Start: 2022-07-21End: 2027-12-01Updated: 2026-09-09

Phase 3

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

Active, not recruitingNCT04573023

JCR Pharmaceuticals Co., Ltd.Mucopolysaccharidosis II

Start: 2022-02-14End: 2027-10-31Updated: 2026-06-04

Phase 4

Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy

CompletedNCT00607386

ShireHunter Syndrome, MPS II, Mucopolysaccharidosis II

Start: 2007-12-31End: 2011-07-08Updated: 2021-06-08

Unknown Phase

An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients

CompletedNCT00882921

ShireHunter Syndrome

Start: 2008-10-14End: 2013-02-08Updated: 2021-06-08

A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723

CompletedNCT01602601

GlaxoSmithKlineMucopolysaccharidosis II

Start: 2012-04-09End: 2012-06-11Updated: 2017-09-25

Related Papers

Evaluation of impact of anti-idursulfase antibodies during long-term idursulfase enzyme replacement therapy in mucopolysaccharidosis II patients.

2017-02-2115 citations

Immunogenicity of idursulfase and clinical outcomes in very young patients (16 months to 7.5 years) with mucopolysaccharidosis II (Hunter syndrome).

2015-04-2420 citations

Development of the multi-attribute Adolescent Health Utility Measure (AHUM).

2012-08-2829 citations