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

NCT ID: NCT01568580

Last Updated: 2012-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2006-09-30

Brief Summary

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

Conditions

Hemophilia A

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

test drug

GreenGene

Group Type: EXPERIMENTAL

GreenGene

Intervention Type: DRUG

Dose : 10 \~ 50IU/kg Administration method : intravenous infusion or bolus

Interventions

GreenGene

Dose : 10 \~ 50IU/kg Administration method : intravenous infusion or bolus

Intervention Type: DRUG

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)

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

GC8AIII

Identifier Type: -

Identifier Source: org_study_id