NCT05566990已完成3 期
A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 11
- 主要终点
- Responder rate (CR or R)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj.10% administered for 2 days in adult subjects with primary immune thrombocytopenia (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 time to response and duration of response, and the safety of LIV-GAMMA SN Inj.10%.
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
- •Completed informed consent process
- •Male or female aged ≥19 years
- •Diagnosis of chronic ITP (≥12 months since diagnosis)
- •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
- •If the patient is taking corticosteroid, attenuated androgen, cyclophosphamide, azathioprine or other drugs for ITP, the treatment regimen and dose should be stable at least 1 month prior to screening and should be lasted during this study
- •Females of child-bearing potential with a negative urine pregnancy test and who agree with contraception during this study
排除标准
- •Patients who have allergy or hypersensitivity to blood products, blood-derived products, intravenous immunoglobulin (IVIg) or immunoglobulin G (IgG)
- •Patients who have immunoglobulin A (IgA) deficiency
- •Patients who were immunized with live attenuated vaccines within 12 months from the first administration of LIV-GAMMA SN Inj.10%
- •Patients who had received IVIg or blood/blood-derived products within 1 month from the first administration of LIV-GAMMA SN Inj.10%
- •Patients who had received other investigational products within 1 month from the first administration of LIV-GAMMA SN Inj.10%
- •Patients who had received Rituximab within 3 months from the first administration of LIV-GAMMA SN Inj.10%
- •Patients who were taking anticoagulants or other agents related to platelet function (e.g., Aspirin, other NSAID) at the time of screening
- •Patients who are pregnant and nursing
- •Patients who are positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at the time of screening
- •Patients who have 3-fold higher levels of alanine transaminase (ALT), aspartate transaminase (AST) than the upper limit of normal at the time of screening
- •Patients who suffered from severe renal impairment (eGFR<30 mL/min/1.73 m^2 at the time of screening)
- •Patients who had history of deep vein thrombosis (DVT) or thrombotic complications against IVIg therapy
- •Patients who had history of neurovascular or cardiovascular disorders (e.g., Blood hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolism, unstable angina)
- •Patients who have an ongoing history of acute or chronic condition that affect to the participation of this study
- •Patients who have an ongoing history of medical condition inducing secondary immune deficiency (e.g., Leukemia, lymphoma, multiple myeloma, HIV infection, chronic or cyclic neutropenia (absolute neutrophil count<500/mm^3)
- •Patients who are suffering from hypertension (systolic blood pressure>160 mmHg or diastolic blood pressure>100 mmHg)
- •Patients who have hemoglobin level≤10 g/dL at the time of screening
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 (CR) defined as cases with a platelet count ≥100×10\^9/L, confirmed on at least 2 separate occasions at least 7 days apart with an absence of bleeding or response (R) defined as cases with a platelet count ≥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 with an absence of bleeding
次要结局
- Duration of response(28 days)
- Time to response(28 days)
- The percentage of subjects with complete response (CR)(28 days)
- Bleeding(28 days)
- Adverse events(28 days)
- The percentage of subjects with response (R)(28 days)
研究者
研究点 (11)
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