Prospective, Non-Randomized, Open-label, Single-arm, Multi-Center Phase III Clinical Trial to Evaluate the Efficacy and Safety of IV-Globulin SN Inj.10% in the Patients Diagnosed With Immune Thrombocytopenia (ITP).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 14
- 主要终点
- % of patients who achieved the platelet count ≥ 50 x 10^9/L increase
研究概览
简要总结
Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.
详细描述
GC5107A (IV-Globulin SN Inj. 10%) is a polyvalent intravenous human immunoglobulin G preparation. It is prepared from plasma collected from more than 1000 healthy blood donors and it expresses the large spectrum of antibody specificity.
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
- •Given written informed consent
- •Male or female aged ≥ 19
- •Primary immune thrombocytopenia (ITP)
- •Platelet <20x10^9 /L
- •Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study
排除标准
- •Patients who have participate in other interventional study within 30 days
- •Inability in written/verbal communication
- •Engaged with an elective surgery
- •Pregnant or breast-feeding women
- •Women of childbearing potential who do not agree with contraception during this study
- •Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
- •Refractory to immunoglobulin therapy
- •Secondary immune thrombocytopenia
- •HIV-associated ITP
- •Lupus-associated ITP
- •Lymphproliferative disease
- •Hepatitis virus carrier
- •Other disease- or infection-associated ITP
- •Drug-Induced ITP
- •Hereditary thrombopenia (e.g., MYH9 disorders)
- •Hemolytic anemia (Positive direct Coomb's test)
- •Clinically significant abnormalities of immunoglobulin
- •Immunoglobulin A Deficiency
- •Immune disorders or deficiency
- •Alcohol or drug abuse within 6 months
- •Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
- •Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
- •Patients who had undergone a splenectomy within 2 months
- •Clinically significant underlying disease or medical history at investigator's discretion
研究组 & 干预措施
Human immunoglobulin intravenous
Human immunoglobulin intravenous; GC5107A (IV-Globulin SN Inj. 10%); Day 1: GC5107A, 1g/kg, intravenous Day 2: GC5107A, 1g/kg, intravenous; Starting infusion rate: 0.01mg/kg/min (1mg/kg/min) for first 15 minutes, and then 2-fold increase every 30 minutes by maximum 0.08ml/kg/min (8mg/kg/min). Dosing modification is allowed due to tolerance.
干预措施: Human immunoglobulin intravenous (Drug)
结局指标
主要结局
% of patients who achieved the platelet count ≥ 50 x 10^9/L increase
时间窗: within 7 days after intervention
次要结局
- Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss(4 weeks after intervention)
- % patient with response(4 weeks after intervention)
- % patient with complete response(4 weeks after intervention)
- Duration of response(4 weeks after intervention)
- Duration of complete response(4 weeks after intervention)
- % patient with no response(4 weeks after intervention)
- Descriptive statistics of platelet count at each visit(4 weeks after intervention)
- Haemorrhage severity rate at each visit(4 weeks after intervention)
- Adverse events(12 weeks after intervention)
- Viral safety(Base line, 4 weeks and 12 weeks after intervention)
- Quality of Life (EQ-5D)(4 weeks after intevention)
- Patient reported bleeding events(12 weeks after intervention)
- Drug compliance(2 days of intervention)
- Usage of rescue mediations(4 weeks after intervention)
- Time to the achievement of platelet count ≥50x10^9/L increase(within 7 days after intervention)