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
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