Hepatitis B, Liver Disease, Liver Transplantation
Conditions
Keywords
hepatitis B, liver transplantation, shortterm HBIg, lamivudine resistance
Brief summary
The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.
Interventions
DRUGEntecavir
Entecavir monotherapy after short-term HBIg therapy for patients transplanted for hepatitis B induced end-stage liver disease; in case of prior lamivudine treatment, tenofovir will be added to the reinfection prophylaxis
Sponsors
Hannover Medical School
HepNet Study House, German Liverfoundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* liver transplantation for hepatitis B induced endstage liver disease * absence of coinfection with HIV and HCV * female and male patients \>= 18 years of age
Exclusion criteria
* any evidence of other causes for endstage liver disease * patients that do not fulfill the criteria for liver transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy | one year |
Secondary
| Measure | Time frame |
|---|---|
| hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation | two years |
Countries
Germany
Outcome results
None listed