Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
32 participants
INTERVENTIONAL
2017-03-09
2022-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
GC1111
GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
Comparator (Part 1)
In Part 1, all participants who randomized into comparator arm should receive the GC1111 for 52 weeks.
Comparator
Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
Interventions
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GC1111
GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
Comparator
Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
MALE
No
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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DongKyu Jin, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsug Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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GC1111_P3
Identifier Type: -
Identifier Source: org_study_id
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