Liver TransplantationPhase 3NCT01046799
Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir
A Phase 3 study testing Entecavir in people with Liver Transplantation and Hepatitis B, run by HepNet Study House, German Liverfoundation at 3 sites in Germany.
Trial summary
The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Hepatitis B, Liver Disease
- What is being tested?
- Entecavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesGermany
- Study dates
- Mar 2008to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver transplantation for hepatitis B induced endstage liver disease
- absence of coinfection with HIV and HCV
- female and male patients >= 18 years of age
Who cannot join
- any evidence of other causes for endstage liver disease
- patients that do not fulfill the criteria for liver transplantation
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Clinic Essen
Essen
Hannover Medical School
Hanover
University Hospital Heidelberg
Heidelberg
About this study
Official title: Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study
The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.
- Conditions
- Liver Transplantation, Hepatitis B, Liver Disease
- Being tested
- Entecavir
- Keywords
- hepatitis B, liver transplantation, shortterm HBIg, lamivudine resistance
- Medical subject headings
- Hepatitis B, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Baraclude
Entecavir monotherapy after short-term HBIg therapy for patients transplanted for hepatitis B induced end-stage liver disease; in case of prior lamivudine treatment, tenofovir will be added to the reinfection prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Entecavir | Experimental | Not described Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
Measured: one year
Secondary outcomes (1)
hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startMar 2008
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HepNet Study House, German Liverfoundation
- Sponsor type
- Research network
- Collaborators
- Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Michael P Manns, MD, Principal investigator, Hannover Medical SchoolHeiner Wedemeyer, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046799
- Sponsor's protocol ID
- 2008-005976-28
- Other IDs
- 2008
- Status last verified
- Nov 2014
- First submitted
- 9 Jan 2010
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study
- ClinicalTrials.gov ID
- NCT01046799
- Acronym / sponsor ID
- 2008-005976-28
- Conditions
- Liver Transplantation, Hepatitis B, Liver Disease
- Keywords
- hepatitis B, liver transplantation, shortterm HBIg, lamivudine resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- HepNet Study House, German LiverfoundationResearch network
- Collaborators
- Hannover Medical School
- Study start
- Mar 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Jan 2010 (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.
The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entecavir | Experimental | Drug: Entecavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- liver transplantation for hepatitis B induced endstage liver disease
- absence of coinfection with HIV and HCV
- female and male patients >= 18 years of age
Key exclusion criteria (2 listed)
- any evidence of other causes for endstage liver disease
- patients that do not fulfill the criteria for liver transplantation
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 |
|---|---|---|
| EntecavirAlso: BaracludeEntecavir monotherapy after short-term HBIg therapy for patients transplanted for hepatitis B induced end-stage liver disease; in case of prior lamivudine treatment, tenofovir will be added to the reinfection prophylaxis | Drug | Entecavir |
Primary outcome
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
Time frame: one year
1 secondary outcome
hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation
Time frame: two years
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 5 Nov 2014.
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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.
Michael P Manns, MD principal investigator
Hannover Medical School
Heiner Wedemeyer, MD principal investigator
Hannover Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entecavir in people with Liver Transplantation and Hepatitis B, run by HepNet Study House, German Liverfoundation at 3 sites in Germany.
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 3 inclusion and 2 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy (time frame: one year). 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 5 Nov 2014.