A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Response Rate at 6 Weeks After Switching
研究概览
简要总结
Thrombopoietin Receptor Agonists (TPO-ra) are novel treatments for patients with refractory Primary Immune Thrombocytopenia (ITP). Rh-TPO and eltrombopag increase the number of platelets through different mechanism. If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer. The purpose of this study is to investigate the efficacy and safety of switching eltrombopag and Rh-TPO in adults with ITP.
详细描述
Non-interventional study. Patients who fail previous steroids and receive rh-TPO and then switch to EPAG or vice versa will be enrolled. The reason for switch will be recorded. Patients in the rh-TPO group were given rh-TPO 300 U/kg once daily for 21 days, and those in the eltrombopag group were given eltrombopag 50mg once daily for 6 weeks. Rh-TPO and eltrombopag were terminated any time the platelet counts increased above 100 × 10^9/L in the rh-TPO group and 300 × 10^9/L in the eltrombopag group. The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 years or older
- •2.Primary ITP
- •3.Platelet count ≤ 30 × 109/l
- •4.Normal neutrophils, reticulocyte count, creatinine and liver enzyme values
- •5.Available follow-up of 2 months at least for each period
- •6.Failed initial glucocorticosteroid treatment
- •7.Unwillingness to accept splenectomy or failed splenectomy
排除标准
- •HIV, hepatitis B or C, Helicobacter pylori infection
- •Congenital or acquired immunologic deficit
- •History of thrombosis plus two or more risk factors
- •Nursing or pregnant women
- •Abnormal liver and renal functions: AST/ALT/total bilirubin ≥1.5 × ULN, creatinine ≥1.5 mg/dl
- •Severe heart and lung dysfunctions -
研究组 & 干预措施
Recombinant human thrombopoietin (rh-TPO) group
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10^9/L. The efficacy, safety, and patient/physician preference will be assessed.
干预措施: Recombinant human thrombopoietin (rh-TPO) (Drug)
Eltrombopag group
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10^9/L.The efficacy, safety, and patient/physician preference will be assessed.
干预措施: Eltrombopag (Drug)
结局指标
主要结局
Response Rate at 6 Weeks After Switching
时间窗: 6 weeks
The percentage of patients who have reached platelet count ≥ 50×10\^9/L at 6 weeks after switching.
次要结局
- Number of Participants With Bleeding Events(6 weeks)
- Treatments Associated Adverse Events(6 weeks)
- Reasons of Switching(6 weeks)
- TOR (Time to Response)(6 weeks)
- DOR (Duration of Response)(6 weeks)
研究者
Xiao Hui Zhang
Clinical Professor
Peking University People's Hospital