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

Green Cross Corporation

Status: Unknown

Conditions: Hunter Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT02044692

GC1111_OS

Details and patient eligibility

About

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

Enrollment: 34 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.