NCT01301898CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Green Cross Corporation
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Primary Outcome
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Years to 35 Years (Child, Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with diagnosis of MPS II based on both clinical and biochemical criteria
- •Male, ages 6 to 35 years old
- •Patients who are able to comply with the study requirements
- •Patients who have given voluntary written consent to participate in the study
- •Patients who is acceptable for using an appropriate method of contraception
Exclusion Criteria
- •History of a tracheostomy or a bone marrow transplant
- •Known hypersensitivity to idursulfase
- •Known shock to idursulfase
- •History of receiving treatment with another investigational therapy within the past 30 days
- •History of a stem cell transplant
- •Known hypersensitivity to any of the components of idursulfase
Arms & Interventions
GC1111_0.5mg/kg
Experimental
Intervention: GC1111_0.5mg/kg (Drug)
GC1111_1.0mg/kg
Experimental
Intervention: GC1111_1.0mg/kg (Drug)
Elaprase_0.5mg/kg
Active Comparator
Intervention: Elaprase_0.5mg/kg (Drug)
Outcomes
Primary Outcomes
Primary Outcome
Time Frame: baseline, every 4 weeks
measurement of % change of Urine GAG
Secondary Outcomes
- Secondary Outcome(baseline, every 12 weeks)
Investigators
Study Sites (1)
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