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| ID | Type | Description | Link |
|---|---|---|---|
| 848223 | Other Grant/Funding Number | European Union | |
| 05.220 | Other Grant/Funding Number | German Center for Infection Research (DZIF) |
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| Name | Class |
|---|---|
| European Union | OTHER |
| German Center for Infection Research | OTHER |
| German Liver Foundation (DLS) | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with change HBsAg levels | Regular assessment of quantitative HBsAg levels | 5 years |
| Number of patients with seroconversion to anti-HBs | Measurement of quantitative HBsAg and anti-HBs levels | 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 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with hepatitis B related increased or decreased quality of life | Regular assessment of QOL by SF36 questionnaires. | 5 years |
| Number of patients with hepatitis B related HCC (hepatocellular carcinoma) |
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Inclusion Criteria:
TherVacB sub-cohort:
Exclusion Criteria:
TherVacB sub-cohort:
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Patients seen in day clinic or outpatient clinic at the participating study centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Dörge | Contact | +49511532 | 6057 | doerge.petra@mh-hannover.de |
| Name | Affiliation | Role |
|---|---|---|
| Markus Cornberg | Hannover Medical School | Principal Investigator |
| Xavier Forns | Fundacio Clinic per a la Recerca Biomedica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Recruiting | Hanover | 30625 | Germany |
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| Label | URL |
|---|---|
| Website of the EU funded part of the registry | View source |
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Undecided which and where data will be shared. Depends on regulatory requirements of EU and German Federal Ministry of Education and Research
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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Regular assessment of HCC status
| 5 years |
| Number of patients with hepatitis B related liver cirrhosis | Regular assessment of liver status | 5 years |
| Number of patients with hepatitis B related death | Regular quantification of lost-to-follow-up reasons. | 5 years |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |