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NCT Number: NCT05051098

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

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).

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Key information

Conditions

Hepatitis B Virus Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, 30625, Germany

Location status: Recruiting

Location contact

Petra Dörge

CONTACT

[email protected]

+49511532 ext. 6057

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Number of patients with change HBsAg levels

    Time frame: 5 years

    Regular assessment of quantitative HBsAg levels

  2. Number of patients with seroconversion to anti-HBs

    Time frame: 5 years

    Measurement of quantitative HBsAg and anti-HBs levels

  3. 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

Secondary outcomes

  1. Number of patients with hepatitis B related increased or decreased quality of life

    Time frame: 5 years

    Regular assessment of QOL by SF36 questionnaires.

  2. Number of patients with hepatitis B related HCC (hepatocellular carcinoma)

    Time frame: 5 years

    Regular assessment of HCC status

  3. Number of patients with hepatitis B related liver cirrhosis

    Time frame: 5 years

    Regular assessment of liver status

  4. Number of patients with hepatitis B related death

    Time frame: 5 years

    Regular quantification of lost-to-follow-up reasons.

Study contacts

Contact information is provided by the study sponsor or research team.

Petra Dörge

CONTACT

[email protected]

+49511532 ext. 6057

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • European Union
  • German Center for Infection Research
  • German Liver Foundation (DLS)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2021
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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