Actively Recruiting
The European HBV Registry: a Joint Initiative of TherVacB and DZIF A Non-interventional Registry for Patients with Hepatitis B Virus Infection
Led by Hannover Medical School · Updated on 2025-03-13
3000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hannover Medical School
Lead Sponsor
E
European Union
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are establishing a European-wide registry to study patients with chronic hepatitis B virus (HBV) infection, including those with HBV mono- and co-infections. This registry aims to analyze virus and host-specific factors in these patients, providing important information to better understand HBV control and help classify patients for future immunomodulatory therapy trials. The project also seeks to identify hepatitis B patients interested in participating in upcoming studies focused on immunotherapies such as therapeutic vaccines. The study involves no interventions or treatments but collects detailed clinical and laboratory data from participants. A subgroup called the TherVacB cohort includes patients with stricter inclusion criteria, such as documented chronic HBV infection and specific virological markers. This observational registry will monitor patients over time to gather information without altering their standard medical care. Participants will undergo evaluations including measurement of hepatitis B surface antigen (HBsAg) levels, seroconversion to anti-HBs antibodies, and quantification of immune markers like IL6, IP-10, IFNg, and IL1beta over five years. Additional assessments cover quality of life, liver health outcomes including cirrhosis and hepatocellular carcinoma, and survival related to hepatitis B. The study will help stratify patients for future clinical trials and improve understanding of HBV infection progression under real-world conditions.
CONDITIONS
Brief Title
A Non-interventional Registry for Patients with Hepatitis B Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hepatitis B Virus Infection
- For the TherVacB subgroup: confirmed chronic hepatitis B infection with HBsAg positive for at least 1 year prior to inclusion
- Documented HBeAg status for at least 6 months for TherVacB subgroup
You will not qualify if you...
- Age over 70 years for TherVacB subgroup
- Co-infection with HIV or hepatitis C virus (RNA positive)
- Clinically relevant liver diseases such as alcoholic liver disease, NASH, haemochromatosis, autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis
- Significant other medical conditions like malignancies
- Immunosuppressive treatment exceeding 40 mg cortisol equivalent
- Liver cirrhosis diagnosed clinically or by imaging
- History of hepatocellular carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants with hepatitis B virus infection are observed over time without intervention to monitor changes in infection markers and health status.
Periodic visits depending on clinical assessment
Trial Site Locations
Total: 1 location
1
Hannover Medical School
Hanover, Germany, 30625
Actively Recruiting
Research Team
P
Petra Dörge
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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