NCT01568580已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Physician's assessment of hemostatic effect for on-demand treatment
研究概览
简要总结
The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
test drug
Experimental
GreenGene
干预措施: GreenGene (Drug)
结局指标
主要结局
Physician's assessment of hemostatic effect for on-demand treatment
时间窗: 12 months
Category: Exellent, Good, Moderate, None
Hemostatic effect for major bleeding
时间窗: up to 1 year
Category: Exellent, Good, Moderate, None
次要结局
- consumption amount of test drug(up to 12 month or 100 exposure days)
- Subject's self assessment of treatment(12 months)
- 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)
研究者
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