A multi-center, prospective, open-label, clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols 10%) in patients with idiopathic (immune) thrombocytopenic purpura.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 10
- 主要终点
- Primary efficacy endpoint:Response rate as defined by the proportion of treated patients in whom platelet counts increase from ≤ 20 x 10.e9/L to ≥ 50 x 10.e9/L by Day 8 ± 1 [where the day of the first infusion is Day 1].
研究概览
简要总结
This study is a multi-center, prospective, open-label, clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols10%) in patients with idiopathic (immune) thrombocytopenic purpura that will be conducted in India, USA and Canada. Globally 75 subjects will be recruited for the study . However from India 30 subjects will be recruited in study from 12 centres . Anticipated date of enrollment for the indian arm would be 1st week of December 2009. Efficacy Endpoint : -Response rate, defined by the proportion of treated patients whose platelet counts increase from ≤ 20 x 10.e9/L to ≥ 50 x 10.e9/L by Day 8 ± 1 (the day of the first infusion is Day 1). -Time to platelet count recovery, defined by the number of days elapsed from Day 1 (the day of the first infusion of the IMP) to the day when the platelet count is first known to be ≥ 50 x 10.e9/L at any moment during the clinical follow-up period ending on Day 30 ± 1. -Duration of response, defined by the number of consecutive days for which the platelet count remains ≥ 50 x 10.e9/L at any moment during the clinical follow-up period ending on Day 30 ± 1. -Regression of hemorrhage/bleedings, defined by the proportion of treated patients with hemorrhage/bleedings at Day 1 (i.e., the day of the first infusion, pre-infusion) who improve their diathesis during the clinical follow-up period ending on Day 15 ± 1. Assessment of regression is made according to a categorized rating scale defined in advance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.To be male or female.
- •2.To be 18 to 70 years of age.
- •3.To have a diagnosis of chronic ITP.
- •4.To have a platelet count ≤ 20 x 10.e9/L.
- •5.To sign an informed consent form.
排除标准
- •1.Has a history or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of the thrombocytopenia.
- •2.Has a diagnosis of secondary immune thrombocytopenia.
- •3.Has a history of severe (e.g. anaphylactic) reactions to blood or any blood-derived product.
- •4.Is suffering a serious and/or life-threatening hemorrhage/bleeding defined as: -Any intracranial or central nervous system bleeding.
- •5.Is known to have IgA deficiency.
- •6.Has a documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past.
- •7.Is anemic (Hgb 9 g/dL).
- •8.Is known to have a positive test for either HIV 1/2 or HCV 9.Has a splenectomy within the prior 8 weeks to the screening visit.
结局指标
主要结局
Primary efficacy endpoint:Response rate as defined by the proportion of treated patients in whom platelet counts increase from ≤ 20 x 10.e9/L to ≥ 50 x 10.e9/L by Day 8 ± 1 [where the day of the first infusion is Day 1].
时间窗: From Day 1 to Day 8 ± 1
次要结局
- Time to platelet count recovery as defined by the number of days elapsed from Day 1 (the day of the first infusion of the IMP) to the day when the platelet count is first known to be 50 x 10.e9/L at any moment during the clinical follow-up period ending on Day 30 ± 1.(Day 1 to Day 30 ±1 Duration of response: from Day 1 to Day 30 ± 1 Regression of hemorrhage/bleedings: from Day 1 to Day 15 ± 1.)