RecruitingNCT05051098

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

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


Sponsor

Hannover Medical School

Enrollment

3,000 participants

Start Date

May 6, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Interventions

OTHERNo intervention

No intervention


Locations(1)

Hannover Medical School

Hanover, Germany

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