Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT00920647
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1/Phase 2
Start date November 18, 2009
Completion date October 29, 2012

See also
  Status Clinical Trial Phase
Recruiting NCT05422482 - A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients With MPS Ⅱ Phase 1
Completed NCT00630747 - Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase Phase 2/Phase 3
Completed NCT03292887 - Hunter Outcome Survey (HOS)
Active, not recruiting NCT02455622 - Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age Phase 4
Completed NCT00882921 - An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
Completed NCT01449240 - Collection and Study of Cerebrospinal Fluid in Patients With Hunter Syndrome
Completed NCT03920540 - A Study of GC1111 in Hunter Syndrom Patients Phase 3
Recruiting NCT06031259 - Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment Phase 2/Phase 3
Completed NCT02055118 - Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment Phase 2/Phase 3
Completed NCT01645189 - Safety and Efficacy of Hunterase Phase 3
Completed NCT00937794 - Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System (CNS) Involvement and Who Are Currently Receiving Treatment With Elaprase®
Recruiting NCT02171104 - MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis Phase 2
Recruiting NCT02044692 - The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients N/A
Completed NCT03582449 - Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)
Completed NCT01822184 - Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
Recruiting NCT05494593 - A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II) Phase 4
Completed NCT00607386 - Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy Phase 4
Completed NCT01043640 - Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders Phase 2
Terminated NCT01330277 - Biomarkers for Hunter Syndrome
Completed NCT01506141 - An 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 Phase 1/Phase 2