A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant (ZEUS)
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| ClinicalTrials.gov Identifier: NCT01856413 |
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Recruitment Status :
Completed
First Posted : May 17, 2013
Last Update Posted : March 25, 2015
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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 |
| 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 |
|---|---|
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Experimental: Zutectra
Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.
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Drug: Zutectra
Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.
Other Names:
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- Trough levels of serum anti-HBs antibody concentrations [ Time Frame: 24 weeks ]
- 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.
- Adverse Events [ Time Frame: 24 weeks ]The number of adverse events will be documented including safety laboratory parameters reported as AEs.
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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
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 ClinicalTrials.gov identifier (NCT number): NCT01856413
| France | |
| Hopital de la Croix Rousse | |
| Lyon, France, 69004 | |
| Hôpital Paul Brousse | |
| Villejuif, France, 94804 | |
| Italy | |
| 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 | |
| Spain | |
| 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 | |
| Principal Investigator: | Didier Samuel, Professeur | Hospital Paul Brousse, Centre Hepato-Biliaire |
| Responsible Party: | Biotest |
| ClinicalTrials.gov 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 |
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Prevention Hepatitis B virus re-infection HBV-DNA negative Liver transplantation |
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Hepatitis A Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Immunoglobulins Immunologic Factors Physiological Effects of Drugs |