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NCT05051098Recruiting

A Non-interventional Registry for Patients With Hepatitis B Virus Infection

The European HBV Registry: A Joint Initiative of TherVacB and DZIF

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
25 Aug 2021
Start date
6 May 2021
Primary completion date
31 Dec 2031
Lead sponsor
Hannover Medical School
Diseases
Hepatitis B
NCT number
NCT05051098

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 6 May 2021 to the primary completion date, 31 Dec 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • clinically relevant concomitant liver diseases (ALD, NASH, Haemochromatosis, Autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis etc.)

Other illness

  • co-infection with HIV, HCV (RNA positive),
  • significant comorbidities (e.g. malignancies)
  • History of hepatocellular carcinoma

Age

  • age \>70 years

Other

  • TherVacB sub-cohort:
  • immunosuppressive treatment (\> 40 mg Cortisol- equivalent)
  • liver cirrhosis (judged clinically or based on ultrasound/transient elastography)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hannover Medical School
Coordinator of this site? Confirm its status
HanoverGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.