To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients
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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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
6 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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