Clinical Trial: The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Long-term Safety of Hunterase (Idursulfase-beta) in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Brief Summary: The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Detailed Summary:
Sponsor: Green Cross Corporation

Current Primary Outcome: Incidence of adverse event and adverse drug reaction. [ Time Frame: Once a week up to 5years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change of vital sign, physical and clinical examination, anti-idurasulfase-beta antibody status. [ Time Frame: Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years) ]

Original Secondary Outcome: Same as current

Information By: Green Cross Corporation

Dates:
Date Received: January 19, 2014
Date Started: January 2014
Date Completion: January 2020
Last Updated: June 19, 2014
Last Verified: June 2014