Hepatitis B Clinical Trial
Official title:
An Open, Prospective, Single Arm Study Investigating Efficacy and Safety of Human Hepatitis B Immunoglobulin Zutectra in Liver Transplanted Patients - the ZEUS Study
Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure
require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved
preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral
antiviral medication. In the first 6 months after liver transplantation, patients receive
treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody
concentrations above 100 IU/L, the level considered safe for preventing hepatitis B
reinfection.
Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for
the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver
transplantation for hepatitis B induced liver failure'. The purpose of this study is to show
that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can
prevent hepatitis B reinfection.
Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of
patients and is more convenient for patients compared to intravenous treatment that must
take place in the hospital setting.
Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy
and Spain. Patients who are eligible for the study will receive treatment with Zutectra for
24 weeks.
During the study, the safety and effectiveness of Zutectra will be assessed by checking for
symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs
antibodies and hepatitis B surface antigen (HBsAg).
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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