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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01301898 |
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Date of registration:
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22/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients
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Scientific title:
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Randomized, Single-blind, Active-controlled, Phase 1/2 Study to Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) Patients |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01301898 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with diagnosis of MPS II based on both clinical and biochemical 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:
1. History of a tracheostomy or a bone marrow transplant
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
Age minimum:
6 Years
Age maximum:
35 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Mucopolysaccharidosis II
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Intervention(s)
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Drug: GC1111_0.5mg/kg
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Drug: GC1111_1.0mg/kg
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Drug: Elaprase_0.5mg/kg
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Primary Outcome(s)
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Primary Outcome
[Time Frame: baseline, every 4 weeks]
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Secondary Outcome(s)
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Secondary Outcome
[Time Frame: baseline, every 12 weeks]
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Secondary ID(s)
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GC1111_P1/2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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