Safety, Tolerability and Efficacy of Single Dose Low Cost Minipool Intravenous Immunoglobulins in Moderately Severe Newly Diagnosed ITP: A Prospective Randomized Study
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- bleeding score(SMOG)
研究概览
简要总结
To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.
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 ≥ 100 x 10^9/L and absence of bleeding (complete response) or platelet count ≥ 50 x 10^9/L and at least 2-fold increase the base line count with absence of bleeding (partial response), within the specified time frame.
详细描述
To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.
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 ≥ 100 x 10^9/L and absence of bleeding (complete response) or platelet count ≥ 50 x 10^9/L and at least 2-fold increase the base line count with absence of bleeding (partial response), within the specified time frame.
Secondary:
- To assess safety of mini-pool IVIG in patients with newly diagnosed ITP by assessing frequency of adverse events related to mini-pool IgG administration
- To compare data on efficacy and safety of mini-pool IVIG with data obtained from literature on standard IVIG.
Study population:
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
- None
入排标准
- 年龄范围
- 12 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newly diagnosed ITP patients (< 2 weeks from onset of the disease), with no platelet enhancing therapy.
- •Age eligible for study: 1-16 years old
- •Gender eligible for study: both sexes
- •Informed consent signed by patient or his legal guardian.
排除标准
- •Patients started on steroid therapy.
- •Platelet count<10,000/mm
- •Having a life threatening bleeding.
- •Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy.
- •Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening.
- •Treatment with any other investigational drug within 7 days before study entry.
研究组 & 干预措施
group B
Standard IVIG single dose 1.0 gm /kg/dose
干预措施: standard IVIG product (Drug)
group C
minipool IVIG product single dose 1.0 gm /kg/dose
干预措施: IVIG prepared by minipool technology (Drug)
结局指标
主要结局
bleeding score(SMOG)
时间窗: 4 weeks
change of bleeding score(SMOG) at day 3,week1,week 2 and week 4 after presentation
complete blood count
时间窗: 4 weeks
change of complete blood count for number of platelets,absolute neutrophil count,absolute lymphocyte count and hemoglobin at day 3,week 1,week 2 and week 4 after presentation
次要结局
- Number of participants with treatment-related adverse events(4 weeks)
研究者
Mohsen Saleh Elalfy
professor
Ain Shams University