A Study of GC1111 in Hunter Syndrom Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|