PROPHYLAXIS OF HEPATITIS B REINFECTION AFTER LIVER TRANSPLANTATION MedDRA version: 9.1 Level: LLT Classification code 10058827 Term: Hepatitis B reactivation
Conditions
Interventions
Product Code: bt088
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Hepatitis B immunoglobulin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Con
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/ HBV-DNA negative in two determinations during the last 3 months  after the last i.v. or i.m. administration of HBIg serum HBs antibody concentration between 200 IU/L and 350 IU/L prior to the first dosing of BT088 at day 1  regular long-term i.v. or i.m. HBIg prophylaxis (combined re-infection prophylaxis) with stabilised HBIg dosage and administration intervals with i.v. or i.m hepatitis B immunoglobulins  stable liver function  written informed consent 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:  bilirubin ≥ 2 mg /dL, albumin less than 2 g/dL, ascites, protrombin less that 70% , ALAT / ASAT / GGT / AP ≥ 2 times ULN (upper limit of normal )  patients who are known to be HBV-DNA positive  hepatocarcinoma (hepatocellular carcinoma)  positive HIV or HCV test  unexplained elevation of liver enzymes  ongoing acute rejection episode  severe thrombocytopenia or any coagulation disorder that would contraindicate injections  pregnancy or unreliable contraceptive measures or lactation period (females only)  known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)  known intolerance to proteins of human origin  selective absolute Ig A deficiency  renal insufficiency (dialysis) or other serious organ dysfunctions  life expectancy below 6 months  suspicion of drug and / or alcohol abuse  inability or lacking motivation to participate in the study  participation in another clinical trial within 90 days before entering the study or during the study and/or previous participation in this study  the patient planned to be enrolled is an employee of any involved investigator or any involved institution including the sponsor of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of safety of the subcutaneous (s.c.) application of BT088 in patients after liver transplantation;Secondary Objective: FEASIBILITY AND EFFICACY;Primary end point(s): N.D. | — |
Countries
Italy
Outcome results
None listed