Clinical trial NCT05051098: A Non-interventional Registry for Patients with Hepatitis B Virus Infection
Official title: The European HBV Registry: a Joint Initiative of TherVacB and DZIF
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B Virus Infection
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: European Union
name: German Center for Infection Research
name: German Liver Foundation (DLS)
First posted: 2021-09-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in day clinic or outpatient clinic at the participating study centers.

Brief 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 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

Primary outcomes:
measure: Number of patients with change HBsAg levels
timeFrame: 5 years
measure: Number of patients with seroconversion to anti-HBs
timeFrame: 5 years
measure: Quantification of IL6, IP-10, IFNg and IL1beta and correlation with HBsAg and ALT levels
timeFrame: 5 years
Secondary outcomes:
measure: Number of patients with hepatitis B related increased or decreased quality of life
timeFrame: 5 years
measure: Number of patients with hepatitis B related HCC (hepatocellular carcinoma)
timeFrame: 5 years
measure: Number of patients with hepatitis B related liver cirrhosis
timeFrame: 5 years
measure: Number of patients with hepatitis B related death
timeFrame: 5 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Markus Cornberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacio Clinic per a la Recerca Biomedica
name: Xavier Forns
role: PRINCIPAL_INVESTIGATOR
References: