To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients

February 12, 2012 updated by: Green Cross Corporation

Randomized, Single-blind, Active-controlled, Phase 1/2 Study to Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) Patients

The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Irwon-dong, Gangnam-Gu
      • Seoul, Irwon-dong, Gangnam-Gu, Korea, Republic of, 135-710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients with diagnosis of MPS II based on both clinical and biochemical criteria
  2. Male, ages 6 to 35 years old
  3. Patients who are able to comply with the study requirements
  4. Patients who have given voluntary written consent to participate in the study
  5. Patients who is acceptable for using an appropriate method of contraception

Exclusion Criteria:

  1. History of a tracheostomy or a bone marrow transplant
  2. Known hypersensitivity to idursulfase
  3. Known shock to idursulfase
  4. History of receiving treatment with another investigational therapy within the past 30 days
  5. History of a stem cell transplant
  6. Known hypersensitivity to any of the components of idursulfase
  7. Female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GC1111_0.5mg/kg
Drug: GC1111_0.5mg/kg
Experimental: GC1111_1.0mg/kg
Drug: GC1111_1.0mg/kg
Active Comparator: Elaprase_0.5mg/kg
Drug: Elaprase_0.5mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: baseline, every 4 weeks
measurement of % change of Urine GAG
baseline, every 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: baseline, every 12 weeks
  • Measurements of the six-minute-walk test (6-MWT)
  • Measurements of liver volume
  • Measurements of heart size and heart function
  • Measurements of joint range of motion
  • Measurements of urine GAG levels
  • Measurements of pulmonary function
  • Evaluate the safety: vital signs, physical examination, laboratory tests, adverse events, immunogenecity
baseline, every 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 12, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC1111_P1/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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