NCT00621673终止4 期
Assessment of the Risk of Inhibitor Formation in Subjects With Severe Hemophilia A When Switched From a Replacement Therapy With a rFVIII Produced by a Chinese Hamster Ovary (CHO) Cell Line to a rFVIII Produced by a Baby Hamster Kidney (BHK) Cell Line (Kogenate® FS).
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 1
- 主要终点
- To evaluate whether a switch of replacement therapy from an rFVIII produced in a CHO cell line to an rFVIII produced in a BHK cell line is associated with a risk of inhibitor formation.
研究概览
简要总结
Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects with severe hemophilia A (< 2% FVIII:C)
- •Subjects with no history of FVIII inhibitor antibody formation
- •Subjects with no measurable inhibitor activity
- •Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in the previous 6 months
- •Subjects whose current treatment with any CHO rFVIII product
- •Subjects with no elective surgery and/or continuous infusion FVIII administration is foreseen during the study
- •Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT) compatible with FVIII deficiency
排除标准
- •Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's disease)
- •Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS or known hypersensitivity to mouse or hamster proteins
- •Any individual with a past history of severe reaction(s) to FVIII concentrates
- •Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry
- •Subjects who were receiving or had received other experimental drugs within 3 months prior to study entry
- •Subjects who require any medication for FVIII infusions
研究组 & 干预措施
Arm 1
Other
干预措施: Kogenate (BAY 14-2222) (Drug)
结局指标
主要结局
To evaluate whether a switch of replacement therapy from an rFVIII produced in a CHO cell line to an rFVIII produced in a BHK cell line is associated with a risk of inhibitor formation.
时间窗: 6 months
次要结局
- To quantify the risk of inhibitor formation, to assess the efficacy of the rFVIII-FS while on regular replacement therapy and to assess the quality-of-life (QoL) before and after the study.(6 months)
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