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 - ND

BIOTEST AG0 个研究点目标入组 40 人开始时间: 2007年3月7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 8805;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 -patients who are known to be HBV-DNA positive -suspicion of drug and / or alcohol abuse

发起方