The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Evaluation of platelet response(continuous response rate)
研究概览
简要总结
The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).
详细描述
62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.
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
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for immune thrombocytopenia.
- •Male or female, between the ages of 10 ~ 70 years.
- •Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective
- •To show a platelet count < 30×10^9/L, or with bleeding manifestations.
- •Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2
排除标准
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- •Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- •Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- •Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- •Patients who are deemed unsuitable for the study by the investigator.
研究组 & 干预措施
group A
In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
干预措施: Rituximab (Drug)
group B
In group B, Rituximab was given with a single dose of 375mg/m2
干预措施: Rituximab (Drug)
结局指标
主要结局
Evaluation of platelet response(continuous response rate)
时间窗: up to 1 year per subject
Complete Response:a sustained (≥ 3 months) platelet count≥100×10\^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia;No response (NR): platelet count \< 30 × 10\^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
次要结局
- therapy associated adverse events(up to 1 year per subject)
研究者
Ming Hou
Professor and Director
Shandong University