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

NCT ID: NCT02044692

Last Updated: 2014-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Hunter Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dong-Kyu Jin

Role: PRINCIPAL_INVESTIGATOR

Samsung medical center, Seoul, Republic of Korea

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong-Kyu Jin

Role: CONTACT

Facility Contacts

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Dongkyu Jin

Role: primary

Other Identifiers

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GC1111_OS

Identifier Type: -

Identifier Source: org_study_id

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