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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05051098

Enrollment

3000

Registered

2021-09-21

Start date

2021-05-06

Completion date

2025-12-31

Last updated

2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Virus Infection

Brief 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. 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).

Interventions

OTHERNo intervention

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with change HBsAg levels	5 years	Regular assessment of quantitative HBsAg levels
Number of patients with seroconversion to anti-HBs	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	5 years	Cytokine and Chemokine quantification in patients for subsequent correlation with viral parameters

Secondary

Measure	Time frame	Description
Number of patients with hepatitis B related increased or decreased quality of life	5 years	Regular assessment of QOL by SF36 questionnaires.
Number of patients with hepatitis B related death	5 years	Regular quantification of lost-to-follow-up reasons.
Number of patients with hepatitis B related HCC (hepatocellular carcinoma)	5 years	Regular assessment of HCC status
Number of patients with hepatitis B related liver cirrhosis	5 years	Regular assessment of liver status

Countries

Germany

Contacts

Primary ContactPetra Dörge

doerge.petra@mh-hannover.de+49511532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026