A Study of GC1111 in Hunter Syndrom Patients
Primary Purpose
Hunter Syndrome
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC1111
Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Hunter Syndrome focused on measuring GC1111, Mucopolysaccharidosis II, MPS II, idursulfase-beta, IDS
Eligibility Criteria
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
Sites / Locations
- Samsug Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GC1111
Comparator
Arm Description
All subjects should receive the GC1111 for 52 weeks.
All subjects should receive the comparator for 52 weeks.
Outcomes
Primary Outcome Measures
Change in 6-MWT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03920540
Brief Title
A Study of GC1111 in Hunter Syndrom Patients
Official Title
Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hunter Syndrome
Keywords
GC1111, Mucopolysaccharidosis II, MPS II, idursulfase-beta, IDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GC1111
Arm Type
Experimental
Arm Description
All subjects should receive the GC1111 for 52 weeks.
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
All subjects should receive the comparator for 52 weeks.
Intervention Type
Combination Product
Intervention Name(s)
GC1111
Intervention Description
GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
Intervention Type
Combination Product
Intervention Name(s)
Comparator
Intervention Description
Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
Primary Outcome Measure Information:
Title
Change in 6-MWT
Time Frame
at Week 53 from baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DongKyu Jin, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsug Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Gyu Jin
Phone
82-2-3410-3695
First Name & Middle Initial & Last Name & Degree
Dong-Gyu Jin
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of GC1111 in Hunter Syndrom Patients
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