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

ConditionHepatitis 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

This trial does not accept healthy volunteers

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 population

Patients seen in day clinic or outpatient clinic at the participating study centers.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: TherVacB Subgroup1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with change HBsAg levels

Regular assessment of quantitative HBsAg levels

Time frame
5 years
2

Number of patients with seroconversion to anti-HBs

Measurement of quantitative HBsAg and anti-HBs levels

Time frame
5 years
3

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

Time frame
5 years

Secondary outcomes

1

Number of patients with hepatitis B related increased or decreased quality of life

Regular assessment of QOL by SF36 questionnaires.

Time frame
5 years
2

Number of patients with hepatitis B related HCC (hepatocellular carcinoma)

Regular assessment of HCC status

Time frame
5 years
3

Number of patients with hepatitis B related liver cirrhosis

Regular assessment of liver status

Time frame
5 years
4

Number of patients with hepatitis B related death

Regular quantification of lost-to-follow-up reasons.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hannover Medical School

Lead sponsor

European Union

Collaborator

German Center for Infection Research

Collaborator

German Liver Foundation (DLS)

Collaborator

Source ClinicalTrials.gov
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