chronic hepatitis B MedDRA version: 9.1 Level: LLT Classification code 10052552 Term: Hepatitis B virus
Conditions
Interventions
Trade Name: Baraclude 0,5 mg
Product Name: Baraclude
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Entecavir
CAS Number: 209216-23-9
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: liver transplantation for hepatitis B-induced end.stage liver disease Absence of coinfection with HIV and HCV Female and male patients > 18 years of age renal function as measured by estimated creatine clearance >30ml/min patients who received a short-term HBIG administration for 4 weeks after liver transplantation the patient is willing ans able to provide written informed concent to participate in the study 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: Any evidence of other causes for end-stage liver disease (e. g. autoimmune hepatitis, hepatitis C, hereditary liver disease,...); Patients that do not fulfil criteria for liver transplantation; Patients with a history or evidence of any intolerance or hypersensitivity to any of the study drugs; Patients with impaired renal function (creatine clearance <30ml/min); Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malsbsorption; Patients who are pregnant or nursing; Co-administration of tenofovir and other medical products containing tenofovir disoproxil fumarate, adefovir dipivixil, didanosine, nephrotoxic medical products; Inability to comply with study procedures; current participation in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to demonstrate that entecavir monotherapy in patients w/o lamivudine resistance or entecavir + tenofovir in patients with preexisting lamivudine resistance is able to prevent HBV reinfection defined by reappearance of HBsAg after liver transplantation only after short-term HBIG administration.;Secondary Objective: - maintain HBsAg negativity in the second year after liver transplantation - evaliation of safety of entecavir alone or in combination with tenofovir in patients after liver transplantation - evaliation of cost efficacy to stop HBIG administration after liver transplantation in combination with entecavir maintenance therapy - evaliation of of HBV-DNA and HBV-RNA in PBMC, serum and in liver biopsies - evaliation of kinetics of anti-HBs and anti-HBc antibody titers as well as HBV-specific cellular immune responses ;Primary end point(s): The primary objective of this study is to demonstrate that entecavir monotherapy in patients w/o lamivudine resistence or entecavir + tevofovir in patients with preexisting lamivudine resistence is able to prevent HBV reinfection fy reappearance4 of HBSAG after liver transplantation only after short-term HBIG administration. Therefore, the primary endpoint is the HBsAg status 12 months after liver transplantation. | — |
Countries
Germany
Outcome results
None listed