An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sobi, Inc.
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations
研究概览
简要总结
Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding.
详细描述
Subjects will receive oral avatrombopag once daily for 5 days beginning on Day 1, followed by a wait period prior to the procedure, which will occur on Day 10 to 13. The Follow-up Period will include 2 visits; 7 days post-procedure and 30 days after last dose.
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
- •Men and women greater than or equal to 18 years of age;
- •A mean baseline platelet count between:
- •50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants
- •50 × 10^9/L and <75 × 10^9/L for participants with chronic liver disease;
- •Participant is scheduled to undergo operations to critical sites (eg, eye surgery, neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), or, in the opinion of the Investigator, would otherwise require a pre-operative platelet transfusion to prevent bleeding
排除标准
- •Participant with a history of arterial or venous thrombosis within 6 months of baseline;
- •Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of baseline;
- •Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Baseline Visit;
- •Use of erythropoietin-stimulating agents;
- •Participant has a known medical history of genetic prothrombotic syndromes; or
- •Participant has abnormal hemoglobin levels or prothrombin time/international normalized ratio
研究组 & 干预措施
Avatrombopag 60 mg
Open-label: oral avatrombopag
干预措施: Avatrombopag 60 mg (Drug)
结局指标
主要结局
Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations
时间窗: Baseline to 10-13 days
Proportion of subjects that achieve a platelet count \>100 x 10\^9 platelets/L on procedure day
次要结局
- Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events(Up to 35 days)