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

Primary Purpose

Hemophilia A

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GreenGene
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring Hemophilia A, Factor VIII, Recombinant

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    test drug

    Arm Description

    GreenGene

    Outcomes

    Primary Outcome Measures

    Physician's assessment of hemostatic effect for on-demand treatment
    Category: Exellent, Good, Moderate, None
    Hemostatic effect for major bleeding
    Category: Exellent, Good, Moderate, None

    Secondary Outcome Measures

    consumption amount of test drug
    Subject's self assessment of treatment
    Category: Exellent, Good, Moderate, None
    FVIII Recovery(%)
    FVIII inhibitor incidence rate
    The number of adverse events
    Surgery study: prohylactic effects
    Category: Exellent, Good, Moderate, None

    Full Information

    First Posted
    March 22, 2012
    Last Updated
    March 29, 2012
    Sponsor
    Green Cross Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01568580
    Brief Title
    Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    September 2006 (Actual)
    Study Completion Date
    September 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Green Cross Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemophilia A
    Keywords
    Hemophilia A, Factor VIII, Recombinant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    test drug
    Arm Type
    Experimental
    Arm Description
    GreenGene
    Intervention Type
    Drug
    Intervention Name(s)
    GreenGene
    Intervention Description
    Dose : 10 ~ 50IU/kg Administration method : intravenous infusion or bolus
    Primary Outcome Measure Information:
    Title
    Physician's assessment of hemostatic effect for on-demand treatment
    Description
    Category: Exellent, Good, Moderate, None
    Time Frame
    12 months
    Title
    Hemostatic effect for major bleeding
    Description
    Category: Exellent, Good, Moderate, None
    Time Frame
    up to 1 year
    Secondary Outcome Measure Information:
    Title
    consumption amount of test drug
    Time Frame
    up to 12 month or 100 exposure days
    Title
    Subject's self assessment of treatment
    Description
    Category: Exellent, Good, Moderate, None
    Time Frame
    12 months
    Title
    FVIII Recovery(%)
    Time Frame
    every 3 months
    Title
    FVIII inhibitor incidence rate
    Time Frame
    every 3 months
    Title
    The number of adverse events
    Time Frame
    up to 1 year
    Title
    Surgery study: prohylactic effects
    Description
    Category: Exellent, Good, Moderate, None
    Time Frame
    up to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

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

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