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

Phase 3

Completed

• Conditions: Hemophilia A
• Interventions: Drug: GreenGene

• Registration Number: NCT01568580
• Lead Sponsor: Green Cross Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-29
• Last Update Submitted: 2012-03-29
• Study First Posted: 2012-04-02
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
test drug	GreenGene	GreenGene

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
consumption amount of test drug	up to 12 month or 100 exposure days
Subject's self assessment of treatment	12 months	Category: Exellent, Good, Moderate, None
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	up to 1 year	Category: Exellent, Good, Moderate, None