April 19, 2019
April 24, 2019
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
All subjects should receive the GC1111 for 52 weeks.
Combination Product: GC1111
GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
|Active Comparator: Comparator
All subjects should receive the comparator for 52 weeks.
Combination Product: Comparator
Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
- Patients diagnosed with Hunter syndrome
- Male at the age of ≥ 5
- Adequate abilities (including 6-MWT) to participate in this study in the opinion of
- Voluntarily signed written informed consent to participation in this study
- Consent to contraception
- Prior treatment with iduronate-2-sulfatase ERT
- History of bronchotomy, bone marrow trasplanation, or cord blood transplanation.
- Known hypersensitivity reactions to any of the components of the invetigational
- Prior or planned administration of other investigational products within 30 days
before treatment with the investigational product in this study or duirng this study.
- Unable to perform 6-MWT.
Korea, Republic of
Samsug Medical Center
Green Cross Corporation
Principal Investigator: DongKyu Jin, M.D., Ph.D. Samsung Medical Center