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NCT Number: NCT01856413

A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant

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).

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital de la Croix Rousse, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent obtained prior to orthotopic liver transplantation (OLT) - not more than 3 months before OLT
  • Historical evidence within the last 4 weeks that HBV-DNA is undetectable at time point of signature of Informed Consent
  • Male and female patients (age 18-75 years)
  • Patients with the diagnosis of liver failure with hepatitis B infection
  • Patients undergoing liver transplantation or re-transplantation
  • HBsAg negative on day 7 or on day 14 after OLT
  • HBV-DNA undetectable at OLT
  • Serum HBs antibody concentration on day 7 or on day 14 after OLT ≥ 400 IU/l
  • Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study
  • Willingness to fill out patient diary

Exclusion criteria

  • Re-transplantation due to viral recurrence
  • Positive HIV or HCV test at time of transplantation
  • HBV-DNA positive at OLT
  • Patients having received organs from HBsAg positive donors
  • Pregnancy or unreliable contraceptive measures or lactation period (females only)
  • Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
  • Known intolerance to proteins of human origin
  • Participation in another interventional clinical trial within 90 days before entering the study or during the study and/or previous participation in this study (except screening failures)
  • Suspicion of drug and/or alcohol abuse
  • Inability or lacking motivation to participate in the study
  • Employee or direct relative of an employee of the CRO, the study site, or Biotest

Treatment and study plan

Zutectra

Drug

Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.

Other names: Human hepatitis B Immunoglobulin, HBIg

Primary outcomes

  1. Trough levels of serum anti-HBs antibody concentrations

    Time frame: 24 weeks

Secondary outcomes

  1. Hepatitis B related re-infections

    Time frame: 24 weeks

    The number of all patients with hepatitis B related infections will be assessed by monitoring of clinical signs, liver function and measurement of HBsAg and HBV-DNA.

Other outcomes

  1. Adverse Events

    Time frame: 24 weeks

    The number of adverse events will be documented including safety laboratory parameters reported as AEs.

Sponsors and collaborators

Lead sponsor

Biotest

Industry

Collaborators

  • AMS Advanced Medical Services GmbH

Registry information

Official study title

An Open, Prospective, Single Arm Study Investigating Efficacy and Safety of Human Hepatitis B Immunoglobulin Zutectra in Liver Transplanted Patients - the ZEUS Study

Acronym: ZEUS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 17, 2013
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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