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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

A Study of GC1111 in Hunter Syndrom Patients

Clinicaltrials.gov identifier NCT03920540

Recruitment Status Recruiting

First Posted April 19, 2019

Last update posted April 24, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Hunter Syndrome
  • Intervention/Treatment: Combination Product: GC1111
    Combination Product: Comparator
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2017
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. Change in 6-MWT [ Time Frame: at Week 53 from baseline ]
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

Korea, Republic of
Samsug Medical Center
Seoul

Sponsors and Collaborators

Green Cross Corporation

Investigators

Principal Investigator: DongKyu Jin, M.D., Ph.D. Samsung Medical Center

More Information
  • 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
  • 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: Mucopolysaccharidosis II
    Mucopolysaccharidoses
    Syndrome