A Non-interventional Registry for Patients with Hepatitis B Virus Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Hepatitis B Virus Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The European HBV Registry: a Joint Initiative of TherVacB and DZIF
Overview
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).
Interventions
- Other No intervention
No intervention
Primary outcome measures
- Number of patients with change HBsAg levels [Time frame: 5 years]
- Number of patients with seroconversion to anti-HBs [Time frame: 5 years]
- Quantification of IL6, IP-10, IFNg and IL1beta and correlation with HBsAg and ALT levels [Time frame: 5 years]
Secondary outcome measures (4)
- Number of patients with hepatitis B related increased or decreased quality of life [Time frame: 5 years]
- Number of patients with hepatitis B related HCC (hepatocellular carcinoma) [Time frame: 5 years]
- Number of patients with hepatitis B related liver cirrhosis [Time frame: 5 years]
- Number of patients with hepatitis B related death [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Hannover Medical School — Hanover
Identifiers
NCT: NCT05051098 · 3374-2016 · 848223 · 05.220