NCT00362349已完成3 期
A Single-arm, Open Label, Multi-centre Study Evaluating the Efficacy and Safety of Ig NexGen 10% in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- Efficacy
研究概览
简要总结
Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by isolated low platelet counts. The aim of treating patients with ITP is to increase the platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy and safety of Ig NextGen 10% in adult patients with ITP.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of ITP
- •platelet count of <50 X 10^9
排除标准
- •planned splenectomy
- •previous non-responders to IVIg treatment
- •known or suspected hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy
- •patients who have received treatment with:
- •IVIg or anti-D immunoglobulin
- •immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration
- •patients who have received IV administration of steroids OR have had a change of oral corticosteroid treatment OR danazol within 15 days prior to first day of study drug administration.
研究组 & 干预措施
1
Experimental
IVIg
干预措施: IgNextGen 10% (Drug)
结局指标
主要结局
Efficacy
时间窗: 90 days
次要结局
- Safety(97 days)
研究者
研究点 (8)
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