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

• Conditions: long-term prophylaxis against hepatitis B re-infection = 3 months after liver transplantation; MedDRA version: 8.0Level: LLTClassification code 10019731

• Registration Number: EUCTR2005-003737-40-DE
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-22
• Last Update Posted: 19 March 2012

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 =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

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 efficacy and safety of two application forms (subcutaneous and intramuscular) of the new human hepatitis B immunoglobulin BT088 in patients after liver transplantation. <br>Trough levels of serum HBs antibody concentrations will be determined in order to ascertain if effective antibody concentrations against a hepatitis B re-infection can be achieved. The pharmacokinetic characteristics of BT088 were evaluated after subcutaneous and intramuscular administration in healthy volunteers in a previous study (study 956).<br>;Secondary Objective: Moreover the feasibility for the subcutaneous self administration will be assessed.<br>;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.