long-term prophylaxis against hepatitis B re-infection = 3 months after liver transplantation MedDRA version: 8.0 Level: LLT Classification code 10019731
Conditions
Interventions
Product Name: Hepatect®SC/IM
Product Code: BT088
Pharmaceutical Form: Solution for injection
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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). ;Secondary Objective: Moreover the feasibility 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. | — |
Countries
Germany, Italy
Outcome results
None listed