A Study of GC1111 in Hunter Syndrom Patients
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|ClinicalTrials.gov Identifier: NCT03920540|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hunter Syndrome||Combination Product: GC1111 Combination Product: Comparator||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||March 9, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
- Change in 6-MWT [ Time Frame: at Week 53 from baseline ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920540
|Korea, Republic of|
|Samsug Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Dong-Gyu Jin 82-2-3410-3695|
|Principal Investigator: Dong-Gyu Jin|
|Principal Investigator:||DongKyu Jin, M.D., Ph.D.||Samsung Medical Center|