A Non-interventional Registry for Patients With Hepatitis B Virus Infection
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: No intervention
No intervention
|
Outcome Measures
Primary Outcome Measures
- Number of patients with change HBsAg levels [5 years]
Regular assessment of quantitative HBsAg levels
- Number of patients with seroconversion to anti-HBs [5 years]
Measurement of quantitative HBsAg and anti-HBs levels
- Quantification of IL6, IP-10, IFNg and IL1beta and correlation with HBsAg and ALT levels [5 years]
Cytokine and Chemokine quantification in patients for subsequent correlation with viral parameters
Secondary Outcome Measures
- Number of patients with hepatitis B related increased or decreased quality of life [5 years]
Regular assessment of QOL by SF36 questionnaires.
- Number of patients with hepatitis B related HCC (hepatocellular carcinoma) [5 years]
Regular assessment of HCC status
- Number of patients with hepatitis B related liver cirrhosis [5 years]
Regular assessment of liver status
- Number of patients with hepatitis B related death [5 years]
Regular quantification of lost-to-follow-up reasons.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hannover Medical School | Hannover | Germany | 30625 |
Sponsors and Collaborators
- Hannover Medical School
- European Union
- German Center for Infection Research
- German Liver Foundation (DLS)
Investigators
- Principal Investigator: Markus Cornberg, Hannover Medical School
- Principal Investigator: Xavier Forns, Fundacio Clinic per a la Recerca Biomedica
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3374-2016
- 848223
- 05.220