An open, prospective, single-arm study investigating safety and efficacy of the human hepatitis B immunoglobulin BT088 after subcutaneous application in liver transplanted patientsClinical Phase: III - STUDY 974

• Conditions: PROPHYLAXIS OF HEPATITIS B REINFECTION AFTER LIVER TRANSPLANTATION; MedDRA version: 9.1Level: LLTClassification code 10058827Term: Hepatitis B reactivation

• Registration Number: EUCTR2008-007625-39-IT
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.