NCT05392647尚未招募2 期
Hetrombopag for Lower-risk MDS With Thrombocytopenia: a Prospective，Open-label, Single-arm Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- Platelet response
研究概览
简要总结
The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in lower-risk MDS patients with thrombocytopenia.
详细描述
The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in patients with very low, low, or intermediate risk myelodysplastic syndromes(MDS) according to the revised International Prognostic Scoring System (IPSS-R) with thrombocytopenia. The primary endpoint was proportion of patients achieving platelet response at week 24.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older；
- •Confirmed diagnosis of MDS based on 2016 WHO (World Health Organization) and classification with very low, low or intermediate (score ≤ 3.5) risk according to the revised International Prognostic Scoring System (IPSS-R).
- •Platelets < 30 x 10^9/L or platelets < 50 x 10^9/L with active bleeding at screening.
- •Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2；
- •Ability to understand information material and written informed consent.
排除标准
- •Severe active bleeding/infection or any other uncontrolled severe condition;
- •History of treatment with thrombopoietin receptor agonists (eltrombopag, avatrombopag, romiplostim, etc.) or recombinant human thrombopoietin with 1 month prior;
- •Patients with known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening（If hepatitis B surface antigen or hepatitis B core antibody are positive, HBV-DNA testing are needed. If positive, it suggests a viral replication and subjects will be excluded. If hepatitis C antibody are positive, HCV-RNA testing are needed. If positive, it suggests a viral replication and subjects will be excluded）;
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 x upper limit of normal (ULN), total bilirubin >2.5 x ULN, creatinine >1.5 x ULN;
- •History of portal hypertension or cirrhosis；
- •History of any types of solid tumors within 5 years prior, whether the tumors has been treated, metastasized or relapsed (except basal cell carcinoma);
- •History of congestive heart failure requiring medical management, cardiac arrhythmias, peripheral arteriovenous thrombosis within 1 years prior, or myocardial infarction or cerebral infarction within 3 months prior;
- •ECOG performance score ≥ 3;
- •Female subjects who are pregnant or breastfeeding, or subjects who are planning pregnancy within 6 months;
- •Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation;
- •Participated in other clinical trials within 3 months prior;
- •Any condition which, in the investigator's opinion, deems the subject an unsuitable candidate to receive study drug.
研究组 & 干预措施
Single arm
Experimental
Hetrombopag
干预措施: Hetrombopag (Drug)
结局指标
主要结局
Platelet response
时间窗: 24 weeks
proportion of patients achieving platelet responses at week 24
次要结局
- Adverse events(28 weeks)
- Overall response rate(24 weeks)
- Proportion of patients with platelet response during treatment(24 weeks)
- Incidence and severity of bleeding events according to the WHO Bleeding Scale(28 weeks)
研究者
Jia Wei
associate chief physician
Tongji Hospital
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