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Safety and Efficacy of Hunterase — GC1111  

Hunter Syndrome Clinical Trial

Official title:
To Evaluate the Safety and Efficacy of Hunterase(Idursulfase-beta) in Hunter Syndrome Patients < 6 Years of Age Receiving Idursulfase Enzyme Replacement Therapy

Clinical Trial Summary

The objective of this study is to determine the safety and efficacy of once weekly dosing of idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome patients < 6 years old.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01645189
Study type Interventional
Source Green Cross Corporation
Contact
Status Completed
Phase Phase 3
Start date July 2012
Completion date September 2013
View Details
See also
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Completed NCT00882921 - An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
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Completed NCT01822184 - Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
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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