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

Conditions: long-term prophylaxis against hepatitis B re-infection 3 months after liver transplantation
MedDRA version: 9.1Level: LLTClassification code 10019731Term: Hepatitis B

Registration Number: EUCTR2005-003737-40-IT

Lead Sponsor: BIOTEST AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective of this phase III study is to demonstrate the efficacy of two application forms subcutaneous and intramuscular of the new human hepatitis B immunoglobulin BT088 in patients after liver transplantation. Baseline adjusted trough levels will provide information if effective serum HBs antibody concentrations 100 IU/L are achieved. The pharmacokinetic characteristics of BT088 were evaluated after subcutaneous and intramuscular administration in healthy volunteers in a previous study study 956 .;Secondary Objective: Moreover the feasiblity for the subcutaneous self administration will be assessed.;Primary end point(s): The aim of the present study is to investigate the safety and efficacy of the new preparation BT088 in stable patients during long-term treatment for prophylaxis against re-infection of a transplanted liver.

Secondary Outcome Measures