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Safety and Efficacy of Hunterase (GC1111)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01645189
First received: July 16, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes

July 16, 2012
April 12, 2013
July 2012
September 2013   (final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01645189 on ClinicalTrials.gov Archive Site
  • change of anti-idursulfase-beta antibody status [ Time Frame: baseline and one year ] [ Designated as safety issue: Yes ]
  • Percent Change of Urine GAG [ Time Frame: baseline to 53 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Hunterase
To Evaluate the Safety and Efficacy of Hunterase(Idursulfase-beta) in Hunter Syndrome Patients < 6 Years of Age Receiving Idursulfase Enzyme Replacement Therapy

The objective of this study is to determine the safety and efficacy of once weekly dosing of idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome patients < 6 years old.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hunter Syndrome
Biological: Hunterase
once weekly, 0.5mg/kg IV infusion
Experimental: Test drug
Idursulfase-beta
Intervention: Biological: Hunterase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The patient has a diagnosis of Hunter syndrome based upon biochemical criteria:

    • as measured in plasma, leukocytes, or fibroblasts,

      • a deficiency in iduronate-2-sulfatase (I2S) enzyme activity of ≤ 10 % of the lower limit of the normal range

    • That corresponds to one or more of the following:

      • a normal enzyme activity level of one other sulfatase
      • Confirmed as MPS2 by genetic test results
      • shows clinical symptoms/ visible signs of MPS2
  2. < 6 years old and male
  3. Patients who are able to comply with the study requirements
  4. The patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study

Exclusion Criteria:

  1. The patient has had a tracheostomy
  2. The patient has known severe hypersensitivity or shock to any of the components of idursulfase
  3. The patient has received treatment with another investigational therapy within 30 days prior to enrollment
  4. History of a stem cell transplant
  5. The patient has known severe hypersensitivity or shock to any of the components of test drug(excipient etc)
Male
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01645189
GC1111_C_P3b
No
Green Cross Corporation
Green Cross Corporation
Not Provided
Principal Investigator: Dong-Kyu Jin Samsung medical center, Seoul, Republic of Korea
Green Cross Corporation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP