NCT00989196已完成2 期
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of Human-cl rhFVIII, a Newly Developed Human Cell-line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 22
- 试验地点
- 15
- 主要终点
- The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS
研究概览
简要总结
This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe hemophilia A (FVIII:C <= 1%)
- •Male subjects between 12 and 65 years of age
- •Body weight 25 kg to 110 kg
- •Previously treated with FVIII concentrate for at least 150 EDs
排除标准
- •Other coagulation disorder than hemophilia A
- •Present or past FVIII inhibitor activity
研究组 & 干预措施
Kogenate FS
Active Comparator
干预措施: Kogenate FS (Biological)
Human-cl rhFVIII
Experimental
干预措施: Human-cl rhFVIII (Biological)
结局指标
主要结局
The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS
时间窗: At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.
After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.
次要结局
- Time to Reach Maximum Plasma Concentration (Tmax) for Human-cl rhFVIII Compared to Kogenate FS(At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.)
- Mean Residence Time (MRT) for Human-cl rhFVIII Compared to Kogenate FS(At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.)
- Volume of Distribution at Steady State (Vss) for Human-cl rhFVIII Compared to Kogenate FS(At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.)
- Clearance (CL) for Human-cl rhFVIII Compared to Kogenate FS(At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.)
- Efficacy of On-demand Treatment of Bleeding Episodes(From 1st treatment after PK cycle 2 until study end.)
- Invivo Half-life (T1/2) for Human-cl rhFVIII Compared to Kogenate FS(At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.)
- Maximum Plasma Concentration (Cmax) for Human-cl rhFVIII Compared to Kogenate FS(At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.)
- Immunogenicity (Number of Patients That Developed an Inhibitor During the Course of the Study)(study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for)
研究者
研究点 (15)
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