NCT00411801终止3 期
A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Octapharma
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change from baseline in (log) platelet count 1 month after treatment initiation
研究概览
简要总结
Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific. Transfusing a patient with an incorrect blood group may have fatal consequences. Uniplas is a universally applicable human plasma, which can be administered irrespective of the patient's blood group. This study will test the safety and efficacy of Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •18 years of age and above.
- •Definite diagnosis of acute thrombotic thrombocytopenic purpura (TTP).
- •Thrombocytopenia.
- •Diagnostic signs of microangiopathic hemolytic anemia.
排除标准
- •Congenital thrombotic microangiopathies.
- •Alternative secondary cause for microangiopathy.
- •Co-morbid illness limiting life expectancy to less than 3 months independent of TTP.
- •Patients known to be HIV positive.
- •Patients known to have lupus.
- •Refusal to accept blood products.
结局指标
主要结局
Change from baseline in (log) platelet count 1 month after treatment initiation
时间窗: Baseline to Month 1
Log platelet count was reported in units, where 1 unit = 10\^9/L platelets.
次要结局
- Percentage of participants who died at 1 and 3 months after treatment initiation(Baseline to Month 3)
- Total volume of plasma exchange fluid administered during treatment cycles up to 1 month(Baseline to Month 1)
- Percentage of participants with a complete response (CR), a partial response (PR), a non-response (NR), or a transient response (TR) after the first treatment cycle and at 1 month(Baseline to Month 1)
- Time to reach maximum platelet count(Baseline to the end of the study (up to 7 months))
- Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study(Baseline to the end of the study (up to 7 months))
研究者
研究点 (2)
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