NCT01349790已完成3 期
Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia
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
- Octapharma
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Responders
研究概览
简要总结
NewGam is a newly developed human normal immunoglobulin solution for intravenous administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in patients with primary immune thrombocytopenia.
详细描述
The primary objective of the study is to assess the efficacy of NewGam in correcting the platelet count. The secondary objective of the study is to evaluate the safety of NewGam. Safety will be assessed by monitoring vital signs, physical examination, evaluation of adverse events (AE) and laboratory parameters, and viral safety testing.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of ≥ 18 and ≤ 65 years.
- •Confirmed diagnosis of chronic primary immune thrombocytopenia (ITP) (diagnosed with a threshold platelet count < 100x10^9/L) of at least 12 months duration.
- •Platelet count of no more than 20x10^9/L with or without bleeding manifestations.
- •Freely given written informed consent from patient.
- •Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropin [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.
排除标准
- •Thrombocytopenia secondary to other diseases (such as acquired immunodeficiency syndrome [AIDS] or systemic lupus erythematosus [SLE]), or drug-related thrombocytopenia.
- •Administration of intravenous immunoglobulin (IGIV), anti-D immunoglobulin or thrombopoietin receptor agonists, or other platelet enhancing drugs (including immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment, except for:
- •Long-term corticosteroid therapy when the dose has been stable during the preceding 3 weeks and no dosage change is planned until study Day
- •Long-term azathioprine, cyclophosphamide, or attenuated androgen therapy when the dose has been stable during the preceding 3 months and no dosage change is planned until study Day
- •Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
研究组 & 干预措施
NewGam
Experimental
Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
干预措施: NewGam (Drug)
结局指标
主要结局
Percentage of Responders
时间窗: Day 1 to Day 8
A responder is a study participant with an increase in platelets to ≥ 50x10\^9/L within 7 days after the first infusion, ie, by study Day 8.
次要结局
- Percentage of Alternative Responders(Day 1 to Day 22)
- Percentage of Complete Responders(Day 1 to Day 22)
- Percentage of Alternative Responders Who Lost the Response(Day 1 to Day 22)
- Percentage of Complete Responders Who Lost the Response(Day 1 to Day 22)
- Time to a Response(Day 1 to Day 8)
- Time to an Alternative Response(Day 1 to Day 22)
- Time to a Complete Response(Day 1 to Day 22)
- Duration of a Response(Day 1 to Day 22)
- Duration of an Alternative Response(Day 1 to Day 22)
- Duration of a Complete Response(Day 1 to Day 22)
- Platelet Count by Visit(Day 1 to Day 22)
- Maximum Platelet Count(Day 1 to Day 22)
- Percentage of Responders Who Achieved a Normal Platelet Count(Day 1 to Day 22)
- Bleeding Intensity(Day 1 to Day 22)
- Percentage of Participants Who Achieved a Platelet Count > 30x10^9/L(Day 1 to Day 2)
研究者
研究点 (1)
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