Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Evaluation of platelet response (Complete Response)
研究概览
简要总结
The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Rituximab for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to conventional Rituximab therapy.
详细描述
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 refractory ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days,following with a flexible dosage depending on platelet count until the 29th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; the others are selected to receive low-dose of rituximab treatment (given intravenously at a dose of 100 mg weekly, i.e. Day 1, 8, 15, 22). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to conventional rituximab therapy for the treatment of adults with refractory ITP.
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
- 18 Years 至 72 Years（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.
- •Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.
- •To show a platelet count < 30×10^9/L, and with bleeding manifestations.
- •Eastern Cooperative Oncology Group（ECOG）performance status ≤
- •Willing and able to sign written informed consent
排除标准
- •Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- •Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- •5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- •6.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.
- •7.Patients who are deemed unsuitable for the study by the investigator.
研究组 & 干预措施
combination treatment group
120 enrolled patients are randomly picked up to take Rituximab in combination with Rh-TPO at the indicated dose.
干预措施: rituximab; recombinant human thrombopoietin (rhTPO) (Drug)
single treatment group
120 enrolled patients are randomly picked up to take Rituximab at the indicated dose.
干预措施: Rituximab (Drug)
结局指标
主要结局
Evaluation of platelet response (Complete Response)
时间窗: The time frame is up to 3 months per subject
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10\^9/L
Evaluation of platelet response (Response)
时间窗: The time frame is up to 3 months per subject
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia.
Evaluation of platelet response (No Response)
时间窗: The time frame is up to 3 months per subject
NR.No response (NR) was defined as 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.
Evaluation of platelet response (relapses)
时间窗: The time frame is up to 3 months per subject
A relapses was defined as platelet count falls below 30×10\^9/L or bleeding accrues after achieving R or CR.
次要结局
- The number and frequency of therapy associated adverse events(up to 3 months per subject)
研究者
Ming Hou
Professor and Director
Shandong University