Hepatitis B Virus InfectionNCT05051098
A Non-interventional Registry for Patients With Hepatitis B Virus Infection
An observational study of Hepatitis B Virus Infection, run by Hannover Medical School at 1 site in Germany.
Trial summary
In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Virus Infection
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 6 May 2021to 31 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients seen in day clinic or outpatient clinic at the participating study centers.
Who may be able to join
- Hepatitis B Virus Infection
- TherVacB sub-cohort:
- confirmed chronic hepatitis B virus infection: HBsAg positive for at least 1 year prior inclusion
- HBeAg status documented for at least 6 months
Who cannot join
- TherVacB sub-cohort:
- age >70 years
- co-infection with HIV, HCV (RNA positive),
- clinically relevant concomitant liver diseases (ALD, NASH, Haemochromatosis, Autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis etc.)
- significant comorbidities (e.g. malignancies)
- immunosuppressive treatment (> 40 mg Cortisol- equivalent)
- liver cirrhosis (judged clinically or based on ultrasound/transient elastography)
- History of hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, 30625
Petra Dörge, +49511532 ext. 6057, doerge.petra@mh-hannover.de
About this study
Official title: The European HBV Registry: A Joint Initiative of TherVacB and DZIF
In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials.
Extensive analyses of virus and host-specific parameters are to be carried out from these patients. The knowledge gained thereby should contribute to a better understanding of the HBV control and enable patient stratification with regard to immunomodulatory therapies.
Furthermore, hepatitis B patients are to be identified who are willing to participate in future studies to investigate immunotherapies to cure HBV infections (e.g. therapeutic vaccines).
- Conditions
- Hepatitis B Virus Infection
- Being tested
- No intervention
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| TherVacB Subgroup | No interventions. The participating study centers of the EU funded project "TherVacB" recruit patients with stricter inclusion- and exclusion criteria, hence forming a sub-cohort. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with change HBsAg levels
Regular assessment of quantitative HBsAg levels
Measured: 5 years
Number of patients with seroconversion to anti-HBs
Measurement of quantitative HBsAg and anti-HBs levels
Measured: 5 years
Quantification of IL6, IP-10, IFNg and IL1beta and correlation with HBsAg and ALT levels
Cytokine and Chemokine quantification in patients for subsequent correlation with viral parameters
Measured: 5 years
Secondary outcomes (4)
Number of patients with hepatitis B related increased or decreased quality of life
Regular assessment of QOL by SF36 questionnaires.
Measured: 5 years
Number of patients with hepatitis B related HCC (hepatocellular carcinoma)
Regular assessment of HCC status
Measured: 5 years
Number of patients with hepatitis B related liver cirrhosis
Regular assessment of liver status
Measured: 5 years
Number of patients with hepatitis B related death
Regular quantification of lost-to-follow-up reasons.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start6 May 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, German Center for Infection Research, German Liver Foundation (DLS)
- Responsible party
- Sponsor
- Investigators
- Markus Cornberg, Principal investigator, Hannover Medical SchoolXavier Forns, Principal investigator, Fundacio Clinic per a la Recerca Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051098
- Sponsor's protocol ID
- 3374-2016
- Other IDs
- 848223, 05.220
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided which and where data will be shared. Depends on regulatory requirements of EU and German Federal Ministry of Education and Research
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European HBV Registry: A Joint Initiative of TherVacB and DZIF
- ClinicalTrials.gov ID
- NCT05051098
- Acronym / sponsor ID
- 3374-2016
- Conditions
- Hepatitis B Virus Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- European Union, German Center for Infection Research, German Liver Foundation (DLS)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 21 Sep 2021 (actual)
- 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.
In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials.
Extensive analyses of virus and host-specific parameters are to be carried out from these patients. The knowledge gained thereby should contribute to a better understanding of the HBV control and enable patient stratification with regard to immunomodulatory therapies.
Furthermore, hepatitis B patients are to be identified who are willing to participate in future studies to investigate immunotherapies to cure HBV infections (e.g. therapeutic vaccines).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TherVacB Subgroup | – | Other: No interventionNo interventions. The participating study centers of the EU funded project "TherVacB" recruit patients with stricter inclusion- and exclusion criteria, hence forming a sub-cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients seen in day clinic or outpatient clinic at the participating study centers.
Key inclusion criteria (4 listed)
- Hepatitis B Virus Infection
- confirmed chronic hepatitis B virus infection: HBsAg positive for at least 1 year prior inclusion
- HBeAg status documented for at least 6 months
Key exclusion criteria (8 listed)
- age >70 years
- co-infection with HIV, HCV (RNA positive),
- clinically relevant concomitant liver diseases (ALD, NASH, Haemochromatosis, Autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis etc.)
- significant comorbidities (e.g. malignancies)
- immunosuppressive treatment (> 40 mg Cortisol- equivalent)
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 |
|---|---|---|
| No interventionNo intervention | Other | TherVacB Subgroup |
Primary outcome
Number of patients with change HBsAg levels
Time frame: 5 years
Regular assessment of quantitative HBsAg levels
Number of patients with seroconversion to anti-HBs
Time frame: 5 years
Measurement of quantitative HBsAg and anti-HBs levels
Quantification of IL6, IP-10, IFNg and IL1beta and correlation with HBsAg and ALT levels
Time frame: 5 years
Cytokine and Chemokine quantification in patients for subsequent correlation with viral parameters
4 secondary outcomes
Number of patients with hepatitis B related increased or decreased quality of life
Time frame: 5 years
Number of patients with hepatitis B related HCC (hepatocellular carcinoma)
Time frame: 5 years
Number of patients with hepatitis B related liver cirrhosis
Time frame: 5 years
Number of patients with hepatitis B related death
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Website of the EU funded part of the registryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided which and where data will be shared. Depends on regulatory requirements of EU and German Federal Ministry of Education and Research
Related trials for Hepatitis B Virus Infection
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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.
Markus Cornberg principal investigator
Hannover Medical School
Xavier Forns principal investigator
Fundacio Clinic per a la Recerca Biomedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B Virus Infection, run by Hannover Medical School at 1 site 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Dörge (+49511532 ext. 6057, doerge.petra@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with change HBsAg levels (time frame: 5 years). The study lists 3 primary outcomes in all. 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 Oct 2026.