Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 21
- 主要终点
- The change in Platelet count from baseline on day 14 after the first dose
研究概览
简要总结
This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).
详细描述
Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, male or female
- •For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
- •Recurrence after previous treatment with glucocorticoids is ineffective or effective
- •No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
- •Platelet count before enrollment ≤ 30 × 109 / L, or > 30 × 109 / L but with active bleeding
- •Volunteer to participate in the study and sign the informed consent form
排除标准
- •pregnant or lactating
- •Those with a history of thrombosis
- •severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
- •Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
- •In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
- •Severe or uncontrollable infections
- •have a history of mental illness
- •The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
研究组 & 干预措施
experimental group 1
rhTPO injection7500 U ;one time a day; 14 times of administration
干预措施: TPO (Drug)
experimental group 2
rhTPO injection15000 U;one time a day;14 times of administration
干预措施: TPO (Drug)
experimental group 3
rhTPO injection15000 U;1 time every other day, 7 times;
干预措施: TPO (Drug)
experimental group 4
rhTPO injection30000 U；1 time every other day, 7 times;
干预措施: TPO (Drug)
结局指标
主要结局
The change in Platelet count from baseline on day 14 after the first dose
时间窗: for day 14
Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.
时间窗: for day 14
次要结局
- AUCss(up to 28days)
- The change in Platelet count from baseline on day 7 and day28 after the first dose(for day7and day28)
- the total effective rate of treatment in ITP patients on day 7 and day 28(for day7and day28)
- AE(up to 28days)
- Incidence of anti-rhTPO antibodies(up to 28days)
- Cav(up to 28days)