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

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

Official Title
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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

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: GreenGene


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test drug<br>GreenGene | Drug: GreenGene<br>* Dose : 10   50IU/kg Administration method : intravenous infusion or bolus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's assessment of hemostatic effect for on-demand treatment | Category: Exellent, Good, Moderate, None | 12 months | 
| Hemostatic effect for major bleeding | Category: Exellent, Good, Moderate, None | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption amount of test drug |  | up to 12 month or 100 exposure days | 
| Subject's self assessment of treatment | Category: Exellent, Good, Moderate, None | 12 months | 
| FVIII Recovery(%) |  | every 3 months | 
| FVIII inhibitor incidence rate |  | every 3 months | 
| The number of adverse events |  | up to 1 year | 
| Surgery study: prohylactic effects | Category: Exellent, Good, Moderate, None | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemophilia A, Factor VIII, Recombinant