Open, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of Bioven, Manufactured by Biopharma Plasma LLC, in Adult Patients With Chronic Primary Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 12
- 主要终点
- Part (Percent) of Patients With Response (R)
研究概览
简要总结
The study will involve patients with chronic immune thrombocytopenia. This disease is diagnosed in the presence of isolated thrombocytopenia (decrease in platelet count only), except for other reasons. The addition of "chronic" means that the disease lasts more than 12 months.
Patients included in the study will receive Bioven, 10% solution for infusion according to the protocol for the use of IVIG in ITP - at a dose of 0.8-1.0 g / kg 1 time per day for 2 consecutive days, the course dose of 1.6-2.0 g / kg according to the "Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG)", rev. 3, 28 June 2018. After administration of the investigational drug, patients will be under medical supervision for 28 days.
The stay of patients in the study - at least 4 weeks.
详细描述
The investigational drug, IVIG, is used for immunomodulatory therapy in the treatment of autoimmune diseases.
The study will involve patients with chronic immune thrombocytopenia. This autoimmune disease is diagnosed in the presence of isolated thrombocytopenia (decrease in platelet count only), except for other reasons. The addition of "chronic" means that the disease lasts more than 12 months.
Screening stage The patient or her legal representative must sign an informed consent. After the informed consent signing procedure, the patient is screened and assessed for compliance with the inclusion and non-inclusion (exclusion) criteria.
Clinical stage After the patient is included in the study, according to the protocol, he/she is hospitalized and the study drug is administered at a dose of 0.8-1.0 g/kg once a day for 2 days (the course dose is 1.6-2.0 g/kg). The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG) and the Coombs test. This procedure will also be carried out on days 7, 14, 21 and 28 after the first injection of the drug to monitor the patient's performance.
The final stage The blood sampling procedure to determine the above indicators will be carried out on days 7, 14, 21, and 28 after the first administration of the drug to monitor the patient's performance.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Main Group
Patients included in the study will receive the intravenous immunoglobulin (IVIG, Bioven), 10% solution for infusion according to the protocol for the use of IVIG in ITP treatment - at a dose of 0.8-1.0 g / kg once a day for 2 consecutive days, the course dose is 1.6-2.0 g / kg.
The next day after the administration of the drug, the patient undergoes blood sampling to determine the level of platelets, the level of immunoglobulin G (IgG), and the Coombs test.
This procedure will also be carried out on days 7, 14, 21, and 28 after the first injection of the drug to monitor the patient's performance.
干预措施: Intravenous immunoglobulin (IVIG), 10% solution for infusion (Drug)
结局指标
主要结局
Part (Percent) of Patients With Response (R)
时间窗: 28 days after first administration of the study drug
platelet count \>30 x 109 /l and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
次要结局
- Part (Percent) of Patients With Complete Response (CR)(28 days after first administration of the study drug)
- Part (Percent) of Patients With no Response (NR)(28 days after first administration of the study drug)
- Part (Percent) of Patients With Loss of Response (R)(28 days after first administration of the study drug)
- Part (Percent) of Patients With Loss of Complete Response (CR)(28 days after first administration of the study drug)
- Time (in Days) From Treatment Start to Response (R)(28 days after first administration of the study drug)
- Time (in Days) From Treatment to Complete Response (CR)(28 days after first administration of the study drug)
- Duration (in Days) of Response (R)(28 days after first administration of the study drug)
- Duration (in Days) of Complete Response (CR)(28 days after first administration of the study drug)