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).
Study Type
OBSERVATIONAL
Enrollment
3,000
No intervention
Hannover Medical School
Hanover, Germany
RECRUITINGNumber of patients with change HBsAg levels
Regular assessment of quantitative HBsAg levels
Time frame: 5 years
Number of patients with seroconversion to anti-HBs
Measurement of quantitative HBsAg and anti-HBs levels
Time frame: 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
Time frame: 5 years
Number of patients with hepatitis B related increased or decreased quality of life
Regular assessment of QOL by SF36 questionnaires.
Time frame: 5 years
Number of patients with hepatitis B related HCC (hepatocellular carcinoma)
Regular assessment of HCC status
Time frame: 5 years
Number of patients with hepatitis B related liver cirrhosis
Regular assessment of liver status
Time frame: 5 years
Number of patients with hepatitis B related death
Regular quantification of lost-to-follow-up reasons.
Time frame: 5 years
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