Comparing the Efficacy and Safety of Optimized rhTPO Treatment Versus Eltrombopag Treatment in Previously Treated Primary Immune Thrombocytopenia Patients: A Multicenter Randomized Open-label Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 17
- 主要终点
- Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation
研究概览
简要总结
TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.
详细描述
A multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia. Total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10^9/L during 6 weeks observation".
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥18 years old.
- •Disease duration is ≥3 months, diagnosed and treated as ITP prior to screening.
- •Baseline platelet count <30×10^9/L.
- •Subjects treated with maintenance corticosteroids or immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
- •Informed consent has been signed.
排除标准
- •Classified as refractory ITP.
- •Subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year.
- •Subjects who have previously received any platelet increasing drug such as rhTPO, thrombopoietin receptor agonist(TPO-RA), etc. within 30 days.
- •Subjects who are known nonresponders to rhTPO or TPO-RA therapy.
- •Subjects with positive hepatitis C virus antibody or human immunodeficiency virus(HIV) antibody, positive HBsAg and serum levels of hepatitis B virus (HBV) DNA >1000cps/ml.
- •TBil or Scr> 1.5 x upper limit of normal (ULN), ALT or AST> 3.0 x ULN in recently 2 weeks.
- •Subjects with any prior history of tumor.
- •Female subjects who are nursing or pregnant.
- •Any situation that investigate consider not suitable for pts to join the study.
研究组 & 干预措施
Optimized rhTPO treatment
The study in a 2:1 randomization ratio (117 subjects to rhTPO group).
干预措施: rhTPO (Drug)
Eltrombopag treatment
The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
干预措施: Eltrombopag (Drug)
结局指标
主要结局
Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation
时间窗: in 6 weeks treatment
Time from the start of treatment to the first time of achieving a platelet count ≥50x10\^9/L without salvage therapy during the first 6 weeks.
次要结局
- 6 weeks response(after 6 weeks treatment)
- 4 months response(after 4 months treatment)
- Incidence of adverse events(from study start date to the end of follow-up, up to 6 months)
- Early response(after 1 week treatment)
- Initial response(after 1 month treatment)
- Durable response(after 6 months treatment)
- Time to treatment failure(in 6 weeks treatment)
- The duration time with platelet count ≥50x10^9/L(in 6 weeks treatment)
- Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0(from study start date to the end of follow-up, up to 6 months)
- Number of subjects who develop anti-rhTPO antibodies(from study start date to the end of follow-up, up to 6 months)