A Study of GC1111 in Hunter Syndrom Patients
Phase 3
Completed
- Conditions
- Hunter Syndrome
- 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
- 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
Samsug Medical Center🇰🇷Seoul, Korea, Republic of