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

• Conditions: Hunter Syndrome

• Registration Number: NCT02044692
• Lead Sponsor: Green Cross Corporation

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 Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-19
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-19
• Last Update Posted: 2014-06-20
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II).
• Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta.
• Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study.

Exclusion Criteria

• Patients who have participated in any other blind clinical trials.
• Patient who cannot be tracked about safety.
• Patients who are judged disqualified to participate clinical trials by investigator for other causes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse event and adverse drug reaction.	Once a week up to 5years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of