Zutectra Early USe - ZEUS Study. Version 1.0

• Research type

  Research Study

• Full title

  An open, prospective, single arm study investigating efficacy and safety of human hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study

• IRAS ID

  109946

• Contact name

  David Mutimer

• Sponsor organisation

  Biotest AG

• Eudract number

  2012-002516-51

• Research summary

  Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require long-term therapy to prevent HBV re-infection of the transplanted liver. The approved preventative treatment is a combination of anti-hepatitis B immunoglobulin (HBIg) and oral antiviral medication. In the first 6 months after liver transplantation, patients receive treatment with intravenous HBIg to maintain blood anti-hepatitis B (anti-HBs) antibody concentrations above 100 IU/L, the level considered safe for preventing hepatitis B re-infection. Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the ??prevention of HBV re-infection 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, starting 1 or 2 weeks after liver transplantation, can maintain anti-HBs antibody levels above 100 IU/L and prevent hepatitis B re-infection. 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. Sixty patients will take part in the study at approximately 10 centres in UK, France and Italy. Patients who are eligible for the study will receive treatment with Zutectra either 1 or 2 weeks after their liver transplant, for a period of 24 weeks. During the first 4 weeks of the study, these injections will take place at the study centre. After this, provided anti-HBs antibody levels are stable and the patient is competent to self-inject, they will be provided with Zutectra for self-administering at home. 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 anti-HBs antibodies and hepatitis B protein, HBsAg.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0347

• Date of REC Opinion

  4 Sep 2012

• REC opinion

  Further Information Favourable Opinion