NCT01194804已完成2 期
Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Change From Baseline in Lactate Dehydrogenase
研究概览
简要总结
The objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.
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
- •Patients must have fully completed C07-001 study 12-week treatment period
排除标准
- •Patients who terminated early from the C07-001 study
研究组 & 干预措施
Eculizumab
Experimental
Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol
干预措施: Eculizumab (Drug)
结局指标
主要结局
Change From Baseline in Lactate Dehydrogenase
时间窗: 52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)
次要结局
- Change From Baseline in FACIT-Fatigue Scale Total Score(52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study))
- Change From Baseline in PNH Red Blood Cell (RBC) Count(52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study))
- Change From Baseline in Number of Units of Packed RBCs Transfused(52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study))
- Change From Baseline in Plasma Free Hemoglobin(52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study))
研究者
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