To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients
NCT ID: NCT01301898
Last Updated: 2012-02-14
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
PHASE1/PHASE2
31 participants
INTERVENTIONAL
2010-05-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GC1111_0.5mg/kg
GC1111_0.5mg/kg
GC1111_1.0mg/kg
GC1111_1.0mg/kg
Elaprase_0.5mg/kg
Elaprase_0.5mg/kg
Interventions
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GC1111_0.5mg/kg
GC1111_1.0mg/kg
Elaprase_0.5mg/kg
Eligibility Criteria
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Inclusion Criteria
2. Male, ages 6 to 35 years old
3. Patients who are able to comply with the study requirements
4. Patients who have given voluntary written consent to participate in the study
5. Patients who is acceptable for using an appropriate method of contraception
Exclusion Criteria
2. Known hypersensitivity to idursulfase
3. Known shock to idursulfase
4. History of receiving treatment with another investigational therapy within the past 30 days
5. History of a stem cell transplant
6. Known hypersensitivity to any of the components of idursulfase
7. Female
6 Years
35 Years
MALE
No
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Locations
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Samsung Medical Center
Seoul, Irwon-dong, Gangnam-Gu, South Korea
Countries
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References
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Sohn YB, Cho SY, Park SW, Kim SJ, Ko AR, Kwon EK, Han SJ, Jin DK. Phase I/II clinical trial of enzyme replacement therapy with idursulfase beta in patients with mucopolysaccharidosis II (Hunter syndrome). Orphanet J Rare Dis. 2013 Mar 18;8:42. doi: 10.1186/1750-1172-8-42.
Other Identifiers
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GC1111_P1/2
Identifier Type: -
Identifier Source: org_study_id
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