A Comparative, Open-label, Randomized, Cross-over Phase I Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of Octaplas LG™ vs. Octaplas®
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C
研究概览
简要总结
The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Capable of understanding and complying with all aspects of the protocol.
- •Signed Informed Consent.
- •Capable of understanding the plasmapheresis information sheet and sign it.
- •Healthy male or female volunteers, age 18 years or older.
- •Women must have negative pregnancy test (human chorionic gonadotropin [HCG] based assay).
- •Women must have sufficient methods of contraception (eg, intrauterine device, oral contraception, etc).
- •No clinically relevant abnormalities in medical history and general physical examination.
- •Standard health insurance.
排除标准
- •Pregnancy or lactation.
- •Tattoos within the last 3 months.
- •Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived products within the last 6 months.
- •Hypersensitivity to blood products or plasma proteins.
- •History of angioedema.
- •History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis, or platelet function.
- •Any clinically significant abnormal laboratory values.
- •IgA deficiency.
- •Seropositivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus type 1 or type 2 antibodies.
- •Symptoms of a clinically relevant illness within 3 weeks before the first trial day.
- •History of or suspected drug or alcohol abuse.
- •Subjects currently participating in another clinical study.
- •Any investigational medicinal product administration within the last 4 weeks.
结局指标
主要结局
Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C
时间窗: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI
时间窗: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.
次要结局
- Concentration of Plasmin Inhibitor(From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis)