A comparative, open-label, randomised, cross-over phase I trial in healthy volunteers to investigate the relative efficacy, safety and tolerability of OctaplasLG™ versus Octaplas® SD

Octapharma AG (Switzerland)0 个研究点目标入组 60 人开始时间: 2009年9月4日最近更新: 2015年1月13日

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. Subject must be capable of understanding the plasmapheresis information sheet and sign it
•4. Healthy male or female volunteers, aged 18 years or above
•5. Women must have a negative pregnancy test (human chorionic gonadotrophin [HCG]-based assay)
•6. Women must have sufficient methods of contraception (e.g. intrauterine device, oral contraception, etc.)
•7. Subjects must have no clinically relevant abnormalities in medical history and general physical examination
•8. Standard health insurance

•1. Pregnancy or lactation
•2. Tattoos within the last 3 months
•3. Subject was treated therapeutically with FFP, blood or plasma derived products in the previous 6 months
•4. Subjects have a hypersensitivity to blood products or plasma protein
•5. History of angioedema
•6. History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis or platelet function
•7. Any clinically significant abnormal laboratory values
•8. IgA deficiency
•9. Seropositivity for HBs-Ag, HCV, HIV-1/2 antibodies
•10. Symptoms of a clinically relevant illness within 3 weeks before the first trial day
•11. Subjects with a history of, or suspected, drug or alcohol abuse
•12. Subjects currently participating in another clinical study
•13. Any IMP administration within the last 4 weeks

发起方

Octapharma AG (Switzerland)