A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- The proportion of patients recovered to 100×109/L
研究概览
简要总结
The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.
The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.
This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values < 100×109/L during radioimmunotherapy.
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
- •Understand the research procedure and voluntarily sign the informed consent to participate in the study
- •Subjects ≥18 years of age receiving synchronous/sequential chemotherapeutic therapy
- •Patients with platelet count ≤100×109/L or platelet count decrease ≥ 50×109/L or platelet count > 100×109/L but need to be prophylaxis with hexapopethanolamine tablets
- •Researchers believe that subjects need to be treated with hexapopal.
排除标准
- •The subjects are conducting clinical intervention studies
- •Patients with known or expected allergy or intolerance to the active ingredient or excipient of hexapopar
- •Pregnant or lactating women
- •Other conditions deemed unsuitable for inclusion in the study by the researcher.
研究组 & 干预措施
Single drug group
干预措施: Herombopag Olamine Tablets (Drug)
combined rhTPO group
干预措施: Herombopag Olamine Tablets (Drug)
combined IL-11 group
干预措施: Herombopag Olamine Tablets (Drug)
结局指标
主要结局
The proportion of patients recovered to 100×109/L
时间窗: 14 days after starting treatment with the study drug
The proportion of patients who recovered to 100×109/L within 14 days after starting treatment with the drug was studied
次要结局
- The proportion of patients recovered to 75×109/L(up to 2 months)
- Proportion of patients with treatment delay or dose reduction(up to 2 months)
- Time for platelet recovery to 100×109/L(up to 2 months)
- TRAE(up to 2 months)
研究者
Jun wang
study principal investigator
Hebei Medical University Fourth Hospital