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CompletedNCT01301898Updated Feb 14, 2012

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

A Phase 1/2 interventional study of GC1111_0.5mg/kg and GC1111_1.0mg/kg in Mucopolysaccharidosis II, sponsored by Green Cross Corporation. Completed at 1 site in South Korea. Open to male participants aged 6 Years to 35 Years. Per ClinicalTrials.gov, last updated 2012-02-14.

Sponsored by Green Cross Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
6 Years to 35 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Mucopolysaccharidosis II

Keywords

  • Hunter syndrome
  • MPS II
  • Idursulfase
03

In context

Mucopolysaccharidosis II

73 studies on the registry are indexed under Mucopolysaccharidosis II; 8 are open to participants now.

This study's enrollment of 31 is above the median of 21 across 44 interventional studies indexed under Mucopolysaccharidosis II.

Browse Mucopolysaccharidosis II studies →

Lead sponsor

Green Cross Corporation is the lead sponsor of 63 studies on the registry; 1 is open to participants now.

Browse GC Biopharma Corp. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
31 participants (actual)

Study arms

  • 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

Interventions

  • DrugGC1111_0.5mg/kg
  • DrugGC1111_1.0mg/kg
  • DrugElaprase_0.5mg/kg
06

What researchers measure

Primary outcomes

  1. Primary Outcome

    measurement of % change of Urine GAG

    Time frame: baseline, every 4 weeks

Secondary outcomes

  1. Secondary Outcome

    * 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

    Time frame: baseline, every 12 weeks

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Irwon-dong, Gangnam-Gu 135-710, South Korea
08

References and documents

Publications

  • Sohn YB, Cho SY, Park SW, Kim SJ, Ko AR, Kwon EK, Han SJ, Jin DK. Phase I/II clinical trial of enzyme replacement therapy with idursulfase beta in patients with mucopolysaccharidosis II (Hunter syndrome). Orphanet J Rare Dis. 2013 Mar 18;8:42. doi: 10.1186/1750-1172-8-42. PubMed 23497636 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2010, a primary completion of Mar 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2011
First posted
Feb 23, 2011
Start
May 2010
Primary completionActual
Mar 2011
CompletionActual
Mar 2011
Last update
Feb 14, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01301898
Lead sponsor
Green Cross Corporation
Responsible party
Sponsor
First posted
Feb 23, 2011
Start date
May 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Feb 14, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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