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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
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients

Condition or disease Intervention/treatment Phase
Hunter Syndrome Combination Product: GC1111 Combination Product: Comparator Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: GC1111
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.




Primary Outcome Measures :
  1. Change in 6-MWT [ Time Frame: at Week 53 from baseline ]


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Samsug Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Dong-Gyu Jin    82-2-3410-3695      
Principal Investigator: Dong-Gyu Jin         
Sponsors and Collaborators
Green Cross Corporation
Investigators
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Principal Investigator: DongKyu Jin, M.D., Ph.D. Samsung Medical Center

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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT03920540     History of Changes
Other Study ID Numbers: GC1111_P3
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Green Cross Corporation:
GC1111
Mucopolysaccharidosis II
MPS II
idursulfase-beta
IDS
Additional relevant MeSH terms:
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Mucopolysaccharidosis II
Mucopolysaccharidoses
Syndrome
Disease
Pathologic Processes
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lysosomal Storage Diseases
Mucinoses
Connective Tissue Diseases
Metabolic Diseases
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System