Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Clinical Response
研究概览
简要总结
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
详细描述
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21.
The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria.
- •Platelet count ≤ 20 x 10^9/L.
排除标准
- •Chronic refractory ITP patients.
- •Thrombocytopenia secondary to other diseases, or drug related thrombocytopenia.
- •Administration of IGIV, anti-D, or other platelet enhancing drugs within 30 days before enrollment.
- •Administration of thrombocyte concentrates within 72 hours before baseline.
- •Experimental treatment (eg, rituximab) within 3 months before enrollment.
- •Prophylactic preoperative treatment for elective splenectomy.
- •Severe liver or kidney disease.
- •Pregnant or nursing female.
- •History of hypersensitivity to blood or plasma derived products.
- •Emergency operation.
- •Live viral vaccination within the last month prior to study entry.
- •Known IgA deficiency and antibodies against IgA.
研究组 & 干预措施
Octagam 10% 1 g/kg/day
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
干预措施: Octagam 10% (Drug)
结局指标
主要结局
Percentage of Participants With a Clinical Response
时间窗: Day 2 to Day 7
A clinical response is defined as an increase in platelet count to ≥ 50\*10\^9/L on any day from Day 2 to Day 7.
次要结局
- Time to Achieve a Clinical Response(Day 2 to Day 7)
- Duration of the Clinical Response(Day 2 to the end of the study (Day 63))
- Maximum Platelet Count(Day 2 to the end of the study (Day 63))
- Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7(Day 7)