Status:
RECRUITING
A Non-interventional Registry for Patients with Hepatitis B Virus Infection
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
European Union
German Center for Infection Research
Conditions:
Hepatitis B Virus Infection
Eligibility:
All Genders
18+ years
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 ...
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
Key Trial Info
Start Date :
May 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT05051098
Start Date
May 6 2021
End Date
December 1 2025
Last Update
March 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hannover Medical School
Hanover, Germany, 30625