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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01856413
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : March 25, 2015
AMS Advanced Medical Services GmbH
Information provided by (Responsible Party):

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Zutectra Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : December 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Zutectra
Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.
Drug: Zutectra
Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.
Other Names:
  • Human hepatitis B Immunoglobulin
  • HBIg

Primary Outcome Measures :
  1. Trough levels of serum anti-HBs antibody concentrations [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Adverse Events [ Time Frame: 24 weeks ]
    The number of adverse events will be documented including safety laboratory parameters reported as AEs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01856413

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Hopital de la Croix Rousse
Lyon, France, 69004
Hôpital Paul Brousse
Villejuif, France, 94804
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari, Italy, 70124
S. Orsola Hospital
Bologna, Italy, 40138
Azienda ospedaliera "G. Brutzu" di Cagliari
Cagliari, Italy, CA 09135
Azienda Ospedaliera Ospedale Niguarda Ca Granda-Chirurgia
Milano, Italy, 20162
Liver and Multivisceral Transplant Center, University of Modena and Reggio Emilia
Modena, Italy, 41100
Azienda Ospedialera Universitaria di Padova
Padova, Italy, 35122
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 54124
Fondazione Policlinico Tor-Vergata U.O.C.
Roma, Italy, 00133
Molinette Hospital
Torino, Italy, 10126
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital 12 de Octubre
Madrid, Spain, 28041
United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
AMS Advanced Medical Services GmbH
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Principal Investigator: Didier Samuel, Professeur Hospital Paul Brousse, Centre Hepato-Biliaire
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Responsible Party: Biotest Identifier: NCT01856413    
Other Study ID Numbers: BT 987
2012-002516-51 ( EudraCT Number )
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Biotest:
Hepatitis B virus re-infection
HBV-DNA negative
Liver transplantation
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs