Trial | NCT01568580  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    71
The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).
Study Started
Dec 31
2004
Primary Completion
Sep 30
2006
Study Completion
Sep 30
2006
Last Update
Apr 02
2012
Estimate

Drug GreenGene

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

test drug Experimental

GreenGene

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)
No Results Posted