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

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).

Eligibility

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

Conditions2

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