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Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01568580
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : April 2, 2012
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).

Condition or disease Intervention/treatment Phase
Hemophilia A Drug: GreenGene Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Non-comparative, Multicenter, Phase III for Evaluation of Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Previously Treated Patients With Hemophilia A
Study Start Date : December 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: test drug
Drug: GreenGene
Dose : 10 ~ 50IU/kg Administration method : intravenous infusion or bolus

Primary Outcome Measures :
  1. Physician's assessment of hemostatic effect for on-demand treatment [ Time Frame: 12 months ]
    Category: Exellent, Good, Moderate, None

  2. Hemostatic effect for major bleeding [ Time Frame: up to 1 year ]
    Category: Exellent, Good, Moderate, None

Secondary Outcome Measures :
  1. consumption amount of test drug [ Time Frame: up to 12 month or 100 exposure days ]
  2. Subject's self assessment of treatment [ Time Frame: 12 months ]
    Category: Exellent, Good, Moderate, None

  3. FVIII Recovery(%) [ Time Frame: every 3 months ]
  4. FVIII inhibitor incidence rate [ Time Frame: every 3 months ]
  5. The number of adverse events [ Time Frame: up to 1 year ]
  6. Surgery study: prohylactic effects [ Time Frame: up to 1 year ]
    Category: Exellent, Good, Moderate, None

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hemophilia A patients at least 12 years of age
  • At least 150 treatment exposure-days to previous FVIII products
  • FVIII≤2% at screening or diagnosis (FVIII≤1% for PK study)
  • CD4 Lympocyte cell count>400/㎕
  • Patients willing to cooperate for the study
  • Patient's or legal guardian's consent to participate in the study

Exclusion Criteria:

  • FVIII inhibitor(neutralizing antibody to FVIII)≥0.6 Bethesda Units
  • Coagulation disorders other than hemophilia A (e.g. Idiopathic Thrombocytopenic Purpura, von Willebrand Disease)
  • Platelet count≤100,000㎣
  • Subjects with clinical evidence of symptomatic HIV disease regardless of HIV-seroposive/seronegative
  • Subjects with rFVIII antibody, mouse IgG antibody, or CHO antibody
  • Creatinine levels more than 2 times of reference rage, GOT and GPT levels more than 3 times of reference range, diabetes mellitus or other metabolic disorder
  • Subjects with diastolic blood pressure≥100mmHg not controlled with antihypertensive medications
  • Anemia(hemoglobin<12g/dL)
  • Subjects with severe or life-threatening bleeding just before entry into the trial
  • Subjects with a history of treatment failure due to formation of inhibitor to FVIII
  • Subjects with a history of severe hypersensitive reactions to FVIII concentrate
  • Subjects requiring pre-medication for FVIII infusion(e.g. antihistamines, etc)
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Responsible Party: Green Cross Corporation Identifier: NCT01568580    
Other Study ID Numbers: GC8AIII
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012
Keywords provided by Green Cross Corporation:
Hemophilia A
Factor VIII
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn