An open, prospective, randomised parallel study investigating efficacy and safety of the human hepatitis B immunoglobulin BT088 after subcutaneous or intramuscular application in liver transplanted patients

Biotest AG0 个研究点目标入组 40 人开始时间: 2005年12月22日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-male and female patients (age 18-75 years)
•-= 3 months after liver transplantation
•-HBsAg negative
•-regular long-term HBIg prophylaxis (combined re-infection prophylaxis) with stabilised HBIg dosage and administration intervals
•-stable liver function
•-written informed consent
•-after the last i.v. administration of HBIg baseline serum HBs antibody concentration =200 IU/l – 500 IU/l should be achieved prior to the first dosing of BT088
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-pregnancy or unreliable contraceptive measures or lactation period (women only)
•-known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
•-known intolerance to proteins of human origin
•-participation in another clinical trial within 30 days before entering the study or during the study and/or previous participation in this study
•-inability or lacking motivation to participate in the study
•-selective absolute IgA deficiency
•-positive HIV or HCV test
•-unexplained elevation of liver enzymes
•-ongoing acute rejection episode
•-severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
•-renal insufficiency (dialysis) or other serious organ dysfunctions
•-life expectancy below 6 months
•-administration of plasma preparations or other immunoglobulins during the conduct of the trial

发起方