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

June 19, 2014 updated by: Green Cross Corporation

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Dongkyu Jin
        • Principal Investigator:
          • Dong Kyu Jin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hunter Syndrome(Mucopolysaccharidosis II) Patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse event and adverse drug reaction.
Time Frame: Once a week up to 5years
Once a week up to 5years

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years)

Other Outcome Measures

Outcome Measure
Time Frame
Percent change of urine GAG.
Time Frame: Baseline and every three months up to 5years.
Baseline and every three months up to 5years.
Percent change of 6 minute walking test.
Time Frame: Baseline and every 6 months up to 5years.
Baseline and every 6 months up to 5years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Investigators

  • Principal Investigator: Dong-Kyu Jin, Samsung Medical Center, Seoul, Republic of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 19, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC1111_OS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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