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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHannover Medical School

About this trial

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 criteria

Qualifiers

Hepatitis B Virus Infection

confirmed chronic hepatitis B virus infection: HBsAg positive for at least 1 year prior inclusion

HBeAg status documented for at least 6 months

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • No intervention

Treatment groups

3,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hannover Medical School

Lead sponsor

European Union

Collaborator

German Center for Infection Research

Collaborator

German Liver Foundation (DLS)

Collaborator