NCT05232149招募中2 期
A Randomized, Multi-center, Adaptive Phase IIa/IIb Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Persistent or Chronic Primary Immune Thrombocytopenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment
研究概览
简要总结
The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial.
Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety follow-up period Phase IIb: At present, a preliminary exploratory study (i.e., phase IIa study) will be conducted first. The design of the phase IIb study (including the selection of populations) will be clarified after a relatively clear understanding of the therapeutic effect, value, risks and benefits of the BTK inhibitor for ITP is obtained.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written ICF before the study.
- •Males or females aged from 18 to 80 years (including the marginal values).
- •With a body weight of ≥ 35 kg at screening.
- •Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met
- •Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.
- •Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug.
- •The mean of two platelet counts is less than 30 × 109/L and no platelet count is greater than 35 × 109/L during the screening visit and/or before the first dose.
排除标准
- •Severe hemorrhage occurred within 4 weeks prior to screening.
- •Subjects suffer from severe ITP at screening
- •Subjects have other diseases which mention in protocol
- •Subjects develop intracranial hemorrhage within 6 months prior to screening.
- •Active and uncontrollable infection
- •Subjects have a history of coagulopathy other than ITP
- •Subjects with a history of malignancies.
- •History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- •Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.
- •Subjects with a Medication history and surgical history which mention in protocol
- •Subjects do not meet the criterion of the laboratory test in protocol
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Lower Dose
Experimental
Orelabrutinib is a white, round, uncoated tablet
干预措施: Orelabrutinib( lower dose) (Drug)
Higher Dose
Experimental
Orelabrutinib is a white, round, uncoated tablet
干预措施: Orelabrutinib( higher dose) (Drug)
结局指标
主要结局
Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment
时间窗: 12 weeks
次要结局
- Proportion of subjects who achieve a complete response (CR) over treatment time. CR is defined as a post-treatment platelet count of ≥100 × 109/L(25 weeks)
- Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity(25 weeks)
研究者
研究点 (9)
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