NCT04890041招募中不适用
Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Treatment response
研究概览
简要总结
This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .
详细描述
The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment.
100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women greater than or equal to 14 years of age.
- •Participants diagnosed with primary immune thrombocytopenia with two platelet counts of < 30x10^9/L or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).
- •Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/ day × 14-day rhTPO with no response to treatment (platelet count < 30×109/L after treatment, or platelet count increase less than twice the baseline value, or with bleeding)
- •Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.
排除标准
- •Patients diagnosed with secondary immune thrombocytopenia.
- •A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.
- •Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);
- •Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;
- •Have used rituximab in the past 3 months;
- •Splenectomy in recent 3 months;
- •Those who are not considered suitable for this study by the researcher;
- •Women who are pregnant or who intend to become pregnant in the near future are excluded.
研究组 & 干预措施
Treatment group
Experimental
100 subjects will be enrolled with the indicated treatment dose of TPO-RA
干预措施: TPO-RA (Drug)
结局指标
主要结局
Treatment response
时间窗: From the start of study treatment (Day 1) up to the end of week 6
Percentage of participants whose platelet count achieving response (R) within 6weeks.
次要结局
- Concomitant medication(From the start of study treatment (Day 1) up to the end of week 6)
- Adverse events(From the start of study treatment (Day 1) up to the end of week 6)
- Treatment response(From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.)
- Duration of response(From the start of study treatment (Day 1) up to the end of week 6)
研究者
研究点 (1)
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