Mucopolysaccharidosis Type Ii
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CLINICAL_TRIALS trial_result · 2025-01-23Clinical Trial Update: A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India [Phase 4]
This Phase 4 trial update reports completion of a study evaluating Elaprase (idursulfase) in children and adults with Hunter syndrome in Ind…
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CLINICAL_TRIALS trial_result · 2024-10-28Clinical Trial Update: Hunter Outcome Survey (HOS)
Clinical trial update for the Hunter Outcome Survey (HOS) sponsored by Shire, tracking outcomes in Mucopolysaccharidosis type II (Hunter syn…
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CLINICAL_TRIALS trial_result · 2024-10-22Clinical Trial Update: Longitudinal Study of Bone Disease in Children with Mucopolysaccharidoses (MPS) I, II, and VI
This clinical trial update reports on a longitudinal study of bone disease in children with mucopolysaccharidoses types I, II, and VI. The s…
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CLINICAL_TRIALS trial_result · 2024-10-15Clinical Trial Update: A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ [Phase 1]
A Phase 1 clinical trial is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of intracerebroventricular GC1123 in …
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CLINICAL_TRIALS trial_result · 2024-09-19Clinical Trial Update: MPS II Immunophenotyping
A Duke University-sponsored trial investigating immunophenotyping in mucopolysaccharidosis type II (Hunter syndrome) has been terminated.
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CLINICAL_TRIALS trial_result · 2024-07-03Clinical Trial Update: A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers [Phase 1]
Phase 1 trial evaluating tolerance, safety, and pharmacokinetics of GNR-055 in healthy volunteers has completed; the study is associated wit…
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CLINICAL_TRIALS trial_result · 2024-06-10Clinical Trial Update: A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome
Denali Therapeutics completed a clinical trial in Mucopolysaccharidosis type II investigating potential treatment-responsive biomarkers and …
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CLINICAL_TRIALS trial_result · 2024-05-03Clinical Trial Update: Long Term Follow-up (LTFU) of Subjects Who Received SB-318, SB-913, or SB-FIX
Long-term follow-up study update for subjects treated with Sangamo's SB-318, SB-913, or SB-FIX, evaluating ongoing outcomes in hemophilia B …
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CLINICAL_TRIALS trial_result · 2022-11-14Clinical Trial Update: A Study of JR-141 in Patients With Mucopolysaccharidosis Type II [Phase 1, Phase 2]
Phase 1/2 trial of JR-141 in Mucopolysaccharidosis II has completed.
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CLINICAL_TRIALS trial_result · 2017-12-13Clinical Trial Update: Parental Coping With Challenging Behavior in Mucopolysaccharidosis Type I-III
A clinical trial examining parental coping with challenging behavior in children with mucopolysaccharidosis types I–III has completed.
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CLINICAL_TRIALS trial_result · 2017-09-15Clinical Trial Update: Effects of Adalimumab in Mucopolysaccharidosis Types I, II and VI [Phase 1, Phase 2]
Clinical trial evaluating adalimumab in mucopolysaccharidosis types I, II, and VI has completed phases 1 and 2 with results posted in 2017.
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CLINICAL_TRIALS trial_result · 2014-07-08Clinical Trial Update: Safety and Efficacy of Hunterase [Phase 3]
Phase 3 clinical trial of Hunterase for mucopolysaccharidosis type II has completed; results are not disclosed in the summary.
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CLINICAL_TRIALS research · 2014-06-20Clinical Trial Update: The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients
This update provides information on the ongoing long-term safety study of Idursulfase-beta in patients with Hunter syndrome (Mucopolysacchar…
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FDA label_change · 2013-06-24FDA Approved: ELAPRASE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ELAPRASE (idursulfase) from Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS trial_result · 2012-02-14Clinical Trial Update: To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients [Phase 1, Phase 2]
Clinical trial update announces completion of Phase 1/2 evaluating GC1111 for Hunter syndrome (Mucopolysaccharidosis type II) focusing on sa…
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FDA approval · 2011-03-08FDA Approved: ELAPRASE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Elaprase (idursulfase) from Takeda Pharmaceuticals America, Inc., reflecting a label or indi…
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FDA approval · 2010-11-29FDA Approved: ELAPRASE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ELAPRASE (idursulfase) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2007-10-24FDA Approved: ELAPRASE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ELAPRASE (idursulfase) from Takeda Pharmaceuticals America, Inc. The approval updates the pr…
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FDA approval · 2006-07-24FDA Approved: ELAPRASE — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA approval of ELAPRASE (idursulfase) under the original application for the treatment of mucopolysaccharidosis type II (Hunter syndrome) b…
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FDA approval ·FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome
FDA approved Avlayah (tividenofusp alfa-eknm) to treat neurologic manifestations in individuals with Hunter syndrome (MPS II).