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Last Updated: August 17, 2022

CLINICAL TRIALS PROFILE FOR IDURSULFASE


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All Clinical Trials for idursulfase

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00920647 ↗ A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase® Completed Shire Phase 1/Phase 2 2009-11-18 Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously. A new formulation of idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration. This Phase I/II study is designed to obtain necessary safety and exposure data, as well as secondary and exploratory outcome measures, to be interpreted and used in the design of subsequent clinical trials.
NCT01506141 ↗ Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment Active, not recruiting Shire Phase 1/Phase 2 2010-08-01 This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV) Elaprase enzyme replacement therapy.
NCT01602601 ↗ A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723 Completed GlaxoSmithKline 2012-04-09 Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients who are currently being treated with idursulfase, an enzyme replacement therapy, and in at least a single patient who is naïve to treatment, if possible to recruit. All patients enrolled into the study will have a single blood draw for the analysis of antibodies induced by this enzyme replacement therapy (idursulfase). Patient samples with positive responses to antibodies induced by idursulfase will be used to further evaluate whether the antibodies induced by idursulfase bind to GSK2788723 molecules in vitro and if these antibodies neutralize the bioactivity of GSK2788723 in vitro. Each subject will have a screening visit, which may occur at their regularly scheduled out-patient visit. If the patient consents to participate in the study, a blood sample (total volume of approximately 3mL) for immunogenicity analysis will be drawn before their current treatment infusion
NCT02412787 ↗ Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094 Active, not recruiting Shire Phase 2/Phase 3 2015-10-28 This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT-HIT-094.
NCT02455622 ↗ Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age Active, not recruiting Shire Phase 4 2015-10-28 This long-term study will provide Elaprase treatment to children enrolled in this study and will utilize data from both enrolled patients and Hunter Outcome Survey (HOS) patient registry data to conduct the primary growth analysis to assess changes in height and weight in patients with Mucopolysaccharidosis II (Hunter syndrome) MPS II.
NCT04573023 ↗ A Phase Ⅲ Study of JR-141 in Patients With Mucopolysaccharidosis II Not yet recruiting JCR Pharmaceuticals Co., Ltd. Phase 3 2021-08-31 A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for idursulfase

Condition Name

Condition Name for idursulfase
Intervention Trials
Hunter Syndrome 4
Mucopolysaccharidosis II 3
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Condition MeSH

Condition MeSH for idursulfase
Intervention Trials
Mucopolysaccharidosis II 7
Syndrome 3
Mucopolysaccharidoses 3
Cognitive Dysfunction 1
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Clinical Trial Locations for idursulfase

Trials by Country

Trials by Country for idursulfase
Location Trials
United States 12
United Kingdom 3
Canada 2
Thailand 1
Oman 1
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Trials by US State

Trials by US State for idursulfase
Location Trials
Illinois 3
North Carolina 3
California 1
Washington 1
Utah 1
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Clinical Trial Progress for idursulfase

Clinical Trial Phase

Clinical Trial Phase for idursulfase
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for idursulfase
Clinical Trial Phase Trials
Active, not recruiting 3
Completed 2
Not yet recruiting 2
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Clinical Trial Sponsors for idursulfase

Sponsor Name

Sponsor Name for idursulfase
Sponsor Trials
Shire 4
GlaxoSmithKline 1
JCR Pharmaceuticals Co., Ltd. 1
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Sponsor Type

Sponsor Type for idursulfase
Sponsor Trials
Industry 7
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