A comparison of safety, tolerability and efficacy of universal plasma (Uniplas™ LG) versus standard S/D plasma (Octaplas™ LG) in healthy volunteers: a randomised, double-blind, cross-over trial

Octapharma AG (Switzerland)0 个研究点目标入组 30 人开始时间: 2009年1月14日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Subject must be capable of understanding and complying with all aspects of the protocol
•2. Signed informed consent
•3. Fulfil criteria of plasma donors according to a standard questionnaire for blood components donors of the Department of Blood Group Serology and Transfusion Medicine
•4. Healthy male or female volunteers greater than or equal to 18 years of age
•5. Blood group A, B or AB
•6. Women must have a negative pregnancy test (human chorionic gonadotropin [HCG]-based assay)
•7. Women must have sufficient methods of contraception (e.g. intrauterine device, oral contraception)
•8. Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
•9. Standard health insurance

•1. Pregnancy or lactation
•2. Refusal to accept blood products
•3. Tattoos within the last 3 months
•4. Treatment with fresh frozen plasma (FFP) or blood products in the previous 6 months
•5. Subjects with a history of hypersensitivity reaction in general or hypersensitivity to blood products or plasma protein in particular
•6. History of angioedema
•7. History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis or platelet function
•8. Any other clinically relevant history of disease
•9. Any clinically significant abnormal laboratory values including Immmunoglobulin A (IgA) deficiency
•10. Seropositivity for hepatitis B surface antigens (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus 1/2 (HIV-1/2) antibodies
•11. Symptoms of a clinically relevant illness within 3 weeks before the first trial day
•12. Subjects with a history of, or suspected, drug or alcohol abuse
•13. Subjects participating in another clinical study currently or during the past 1 month

发起方

Octapharma AG (Switzerland)