Records containing: Hunter Syndrome

This is the wording recorded or indexed by the source. An agency index term is not necessarily an authorised indication. Co-listed drug names are not linked to this term as a treatment relationship.

• CLINICAL_TRIALS study record update · 2026-04-13
  Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive Impairment
• CLINICAL_TRIALS study record update · 2026-04-02
  A Long-Term, Open-Label, Multicenter, Phase IV Study to Assess Longitudinal Changes on Height and Weight in Patients With MPS II Who Are Receiving Elaprase and Started Treatment With Elaprase at <6 Years of Age
• CLINICAL_TRIALS study record update · 2026-01-15
  An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta) in Patients With Hunter Syndrome
• CLINICAL_TRIALS study record update · 2026-01-07
  MT2013-31: Allogeneic Hematopoietic Cell Transplantation for Inherited Metabolic Disorders and Severe Osteopetrosis Following Conditioning With Busulfan (Therapeutic Drug Monitoring), Fludarabine +/- ATG
• CLINICAL_TRIALS study record update · 2025-12-09
  An Open-label, Multicenter, Phase 4 Study to Assess the Effects of a Prophylactic Immune Tolerizing Regimen in MPS II Treatment-Naïve Patients Planned to Receive ELAPRASE Who Are at Risk of Developing Persistent Neutralizing Antibodies
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• CLINICAL_TRIALS study record update · 2025-11-06
  An Open-Label Extension for Subjects in Studies HGT-HIT-046 and SHP609-302 Evaluating Long-Term Safety of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Subjects With Hunter Syndrome and Cognitive Impairment
• CLINICAL_TRIALS study record update · 2025-08-06
  An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Pediatric Patients With Hunter Syndrome and Cognitive Impairment
• CLINICAL_TRIALS study record update · 2025-06-19
  An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction With Elaprase® in Patients With Hunter Syndrome and Cognitive Impairment
• CLINICAL_TRIALS study record update · 2025-01-23
  A Prospective, Multicenter, Single-arm, Open-label, Interventional Phase IV Study to Evaluate the Safety and Efficacy of Idursulfase (r-DNA Origin) (Elaprase™) in Indian Pediatric and Adult Population With Hunter Syndrome (Mucopolysaccharidosis II)
• CLINICAL_TRIALS study record update · 2024-10-28
  Hunter Outcome Survey: A Global, Multi-Center, Long-Term, Observational Registry of Patients With Hunter Syndrome (Mucopolysaccharidosis Type II, MPS II)
• CLINICAL_TRIALS study record update · 2024-10-15
  An Open-Label, Phase 1 and Extension Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ Who Have Central Nervous System Involvement and Are Receiving Treatment with Intravenous Drug
• CLINICAL_TRIALS study record update · 2024-09-19
  Immunophenotyping of Patients With MPS II Treated With Enzyme Replacement Therapy
• CLINICAL_TRIALS study record update · 2024-04-16
  Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients
• CLINICAL_TRIALS study record update · 2023-09-15
  Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)
• CLINICAL_TRIALS study record update · 2023-02-10
  Biomarkers for Hunter Syndrome: An International, Multicenter, Observational, Longitudinal Protocol
• CLINICAL_TRIALS study record update · 2021-03-17
  A Prospective, Longitudinal, Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
• CLINICAL_TRIALS study record update · 2018-12-13
  A Controlled, Randomized, Two-arm, Open-label, Assessor-blinded, Multicenter Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
• CLINICAL_TRIALS study record update · 2017-05-12
  Allogeneic Hematopoietic Stem Cell Transplantation for Standard Risk Inherited Metabolic Disorders
• CLINICAL_TRIALS study record update · 2016-05-16
  A Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System Involvement and Who Are Currently Receiving Treatment With Elaprase®
• CLINICAL_TRIALS study record update · 2014-12-05
  A Cerebrospinal Fluid Collection Study in Pediatric and Adult Patients With Hunter Syndrome
• CLINICAL_TRIALS study record update · 2014-07-30
  A Multi-Center Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients Enrolled in the Hunter Outcome Survey (HOS) Receiving Idursulfase Enzyme Replacement Therapy
• CLINICAL_TRIALS study record update · 2014-07-08
  To Evaluate the Safety and Efficacy of Hunterase(Idursulfase-beta) in Hunter Syndrome Patients < 6 Years of Age Receiving Idursulfase Enzyme Replacement Therapy
• CLINICAL_TRIALS study record update · 2014-06-20
  The Long-term Safety of Hunterase (Idursulfase-beta) in Hunter Syndrome(Mucopolysaccharidosis II) Patients
• CLINICAL_TRIALS study record update · 2014-05-16
  A Phase I/II, Randomized, Safety and Ascending Dose Ranging Study of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase in Pediatric Patients With Hunter Syndrome and Cognitive Impairment
• CLINICAL_TRIALS study record update · 2014-03-17
  An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy