This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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: IDS
    GC1111
    Mucopolysaccharidosis II
    MPS II
    idursulfase-beta
  • Additional relevant MeSH terms: Mucopolysaccharidosis II
    Mucopolysaccharidoses
    Syndrome