Study Results
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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COMPLETED
PHASE3
6 participants
INTERVENTIONAL
2012-07-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Test drug
Idursulfase-beta
Hunterase
once weekly, 0.5mg/kg IV infusion
Interventions
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Hunterase
once weekly, 0.5mg/kg IV infusion
Eligibility Criteria
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Inclusion Criteria
* as measured in plasma, leukocytes, or fibroblasts,
* a deficiency in iduronate-2-sulfatase (I2S) enzyme activity of ≤ 10 % of the lower limit of the normal range
* That corresponds to one or more of the following:
* a normal enzyme activity level of one other sulfatase
* Confirmed as MPS2 by genetic test results
* shows clinical symptoms/ visible signs of MPS2
2. \< 6 years old and male
3. Patients who are able to comply with the study requirements
4. The patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study
Exclusion Criteria
2. The patient has known severe hypersensitivity or shock to any of the components of idursulfase
3. The patient has received treatment with another investigational therapy within 30 days prior to enrollment
4. History of a stem cell transplant
5. The patient has known severe hypersensitivity or shock to any of the components of test drug(excipient etc)
5 Years
MALE
No
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Dong-Kyu Jin
Role: PRINCIPAL_INVESTIGATOR
Samsung medical center, Seoul, Republic of Korea
Locations
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Samsug Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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GC1111C
Identifier Type: -
Identifier Source: org_study_id
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