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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Corporation
• Treatments: Factor VIII

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)