NCT00168038已完成3 期
An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 58
- 试验地点
- 17
- 主要终点
- Platelet Response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10^9/L.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic ITP defined by: Failure to find other causes of thrombocytopenia; Platelet count ≤ 150 x 10^9/L over 6 months or response to a previous treatment with subsequent decrease in platelet count even if duration of chronic ITP is less than 6 months
- •Platelet counts ≤ 20 x 10^9/L
排除标准
- •Planned splenectomy throughout the study period
- •Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening
- •Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening
- •Treatment with intravenous steroids within 10 days prior to screening
- •Change of oral steroid treatment within 15 days prior to screening
- •Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy
- •Abnormal results in the following laboratory parameters: Hemoglobin < 10 g/dL; Total bilirubin > 1.5 x upper normal limit; ALAT > 2.5 x upper normal limit; ASAT > 2.5 x upper normal limit; Creatinine > 1.5 x upper normal limit; Urea > 1.5 x upper normal limit
- •Positive direct Coombs test
- •Patients with one of the following concomitant diseases Clinical active SLE Known or suspected HIV infection Acute hepatitis Clinically active chronic hepatitis Lymphoproliferative disease Heart failure Grade III or IV according to the New York Heart Association classification
- •Any other concomitant disease that has influence on the clotting system (i.e. hemophilia)
结局指标
主要结局
Platelet Response
时间窗: 7 days
The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10\^9/L to ≥ 50 x 10\^9/L within the specified time frame.
次要结局
- Regression of Hemorrhage (Skin)(up to 29 days)
- Regression of Hemorrhage (Oral Cavity)(29 days)
- Regression of Hemorrhage (Genitourinary Tract)(29 days)
- Regression of Hemorrhage (Nose)(29 days)
- Regression of Hemorrhage (Internal)(29 days)
- Time to Platelet Response(29 days)
- Duration of Platelet Response(up to 29 days)
- Maximum Platelet Level(29 days)
研究者
研究点 (17)
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