A Study of GC1111 in Hunter Syndrom Patients
Phase 3
Completed
- Conditions
- Hunter Syndrome
- Interventions
- Combination Product: ComparatorCombination Product: GC1111
- Registration Number
- NCT03920540
- Lead Sponsor
- Green Cross Corporation
- Brief Summary
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
- 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 the investigator.
- Voluntarily signed written informed consent to participation in this study
- Consent to contraception
Exclusion Criteria
- 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 product
- 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.
- Female
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator (Part 1) Comparator In Part 1, all participants who randomized into comparator arm should receive the GC1111 for 52 weeks. GC1111 GC1111 In part 1, all participants who randomized into GC1111 arm should receive the GC1111 for 52 weeks. In part 2, all enrolled participants should receive the GC1111 for 52 weeks.
- Primary Outcome Measures
Name Time Method Change in 6-MWT at Week 53 from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsug Medical Center
🇰🇷Seoul, Korea, Republic of