Hepatitis BPhase 3ZEUSNCT01856413
A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant
A Phase 3 study testing Zutectra in people with Hepatitis B, run by Biotest at 16 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Zutectra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Dec 2012to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Italy9 sites
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari, 70124
S. Orsola Hospital
Bologna, 40138
Azienda ospedaliera "G. Brutzu" di Cagliari
Cagliari, CA 09135
Azienda Ospedaliera Ospedale Niguarda Ca Granda-Chirurgia
Milan, 20162
Liver and Multivisceral Transplant Center, University of Modena and Reggio Emilia
Modena, 41100
Azienda Ospedialera Universitaria di Padova
Padova, 35122
Azienda Ospedaliero-Universitaria Pisana
Pisa, 54124
Fondazione Policlinico Tor-Vergata U.O.C.
Roma, 00133
Molinette Hospital
Torino, 10126
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital 12 de Octubre
Madrid, 28041
France2 sites
Hopital de la Croix Rousse
Lyon, 69004
Hôpital Paul Brousse
Villejuif, 94804
United Kingdom2 sites
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, B15 2TH
King's College Hospital
London, SE5 9RS
About this study
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.
Read more
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).
- Conditions
- Hepatitis B
- Being tested
- Zutectra
- Keywords
- Prevention, Hepatitis B virus re-infection, HBV-DNA negative, Liver transplantation
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZutectraDrug
Also called Human hepatitis B Immunoglobulin, HBIg
Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.
| Study group | Role | What they receive |
|---|---|---|
| Zutectra | Experimental | Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week. Receives: Drug: Zutectra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough levels of serum anti-HBs antibody concentrations
Measured: 24 weeks
Secondary outcomes (1)
Hepatitis B related re-infections
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotest
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AMS Advanced Medical Services GmbH
- Responsible party
- Sponsor
- Investigators
- Didier Samuel, Professeur, Principal investigator, Hospital Paul Brousse, Centre Hepato-Biliaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856413
- Sponsor's protocol ID
- BT 987
- Other IDs
- 2012-002516-51
- Acronym
- ZEUS
- Status last verified
- Mar 2015
- First submitted
- 15 May 2013
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01856413
- Acronym / sponsor ID
- ZEUS / BT 987
- Conditions
- Hepatitis B
- Keywords
- Prevention, Hepatitis B virus re-infection, HBV-DNA negative, Liver transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- BiotestIndustry (pharma, biotech, devices)
- Collaborators
- AMS Advanced Medical Services GmbH
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zutectra | Experimental | Drug: ZutectraSubcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZutectraAlso: Human hepatitis B Immunoglobulin, HBIgSubcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week. | Drug | Zutectra |
Primary outcome
Trough levels of serum anti-HBs antibody concentrations
Time frame: 24 weeks
1 secondary outcome
Hepatitis B related re-infections
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Samuel, Professeur principal investigator
Hospital Paul Brousse, Centre Hepato-Biliaire
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zutectra in people with Hepatitis B, run by Biotest at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy, Spain, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough levels of serum anti-HBs antibody concentrations (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.