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

Study Overview
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Brief Summary
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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).

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

Conditions
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Hepatitis B Virus Infection

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TherVacB Subgroup<br>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. | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with change HBsAg levels | Regular assessment of quantitative HBsAg levels | 5 years | 
| Number of patients with seroconversion to anti-HBs | Measurement of quantitative HBsAg and anti-HBs levels | 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 | 5 years | 

Secondary Outcome Measures

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