A Non-interventional Registry for Patients with Hepatitis B Virus Infection
NCT ID: NCT05051098
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2021-05-06
2025-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TherVacB Subgroup
No interventions. The participating study centers of the EU funded project "TherVacB" recruit patients with stricter inclusion- and exclusion criteria, hence forming a sub-cohort.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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European Union
OTHER
German Center for Infection Research
OTHER
German Liver Foundation (DLS)
UNKNOWN
Hannover Medical School
OTHER
Responsible Party
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Principal Investigators
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Markus Cornberg
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Xavier Forns
Role: PRINCIPAL_INVESTIGATOR
Fundacio Clinic per a la Recerca Biomedica
Locations
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Hannover Medical School
Hanover, , Germany
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Website of the EU funded part of the registry
Other Identifiers
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848223
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
05.220
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
3374-2016
Identifier Type: -
Identifier Source: org_study_id
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