A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Responder rate (CR or R)
研究概览
简要总结
The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with ITP. The primary objective of this study is to determine the responder rate. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without bleeding. The secondary objectives are to evaluate the further efficacy assessments including duration of response, and the safety of LIV-GAMMA SN Inj.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ITP
- •Mean screening platelet count of <30×10^9/L from 3 qualifying platelet counts performed within 14 days before the start of treatment, with no individual platelet count above 35×10^9/L.
- •No other factors inducing ITP
- •Stable doses of ITP active treatment must not have modified the dose in the preceding 1 month and must maintain their prestudy dose during the study.
排除标准
- •Known for hypersensitivity reactions to blood products, intravenous immunoglobulin (IVIg) or immunoglobulin G
- •Immunoglobulin A (IgA) deficiency
- •Therapy with live attenuated virus vaccines 3 months before the first administration of LIV-GAMMA SN Inj.
- •Administration of other investigational product 1 month before the first administration of LIV-GAMMA SN Inj.
- •Administration of Rituximab 3 months before the first administration of LIV-GAMMA SN Inj.
- •Treatment with anti-coagulants, which may affect the function of platelet
- •Positive HIV, HBV, HCV
- •3-fold increase of ALT or AST compared to normal upper limit
- •eCFR < 30mL/min/1.73m^2
- •History of deep vein thrombosis (DVT) or IVIg-induced thrombotic compliances
- •Hemoglobin > 10g/dL
结局指标
主要结局
Responder rate (CR or R)
时间窗: 28 days
The rate of subjects with complete response defined as cases with a platelet count ≥100×10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart without bleeding and response, which is defined as cases with a platelet count of ≥30×10\^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart without bleeding
次要结局
- Time to Response(28 days)
- The percentage of subjects with response (R)(28 days)
- Duration of response(28 days)
- The percentage of subjects with complete response (CR)(28 days)
- Bleeding(28 days)