Liver Transplantation | Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir
Liver Transplantation research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:EntecavirEntecavir 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: March 2008
Completed Date: October 2014
Phase: Phase 3
Primary Outcome: prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
Secondary Outcome: hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation
Study sponsors, principal investigator, and references
Principal Investigator: Michael P Manns, MD
Lead Sponsor: HepNet Study House, German Liverfoundation
Collaborator: Hannover Medical School