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

Green Cross Corporation

Status and phase: Completed; Phase 3

Conditions: Hemophilia A

Treatments: Drug: GreenGene

Study type: Interventional

Funder types: Industry

Identifiers

NCT01568580

GC8AIII

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

test drug

Experimental group

Description:

GreenGene

Treatment:

Drug: GreenGene