Registry for patients with hepatitis B virus infection
The European HBV Registry: a Joint Initiative of TherVacB and DZIF
This study is collecting information from people with hepatitis B to better understand the virus and find out who might be interested in trying new treatments like vaccines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 1 site (Hanover) |
| Trial ID | NCT05051098 on ClinicalTrials.gov |
What this trial studies
This registry aims to address the unmet needs in chronic hepatitis B virus (HBV) infection by gathering data from patients with HBV mono- and co-infections across Europe. The consortium of clinical partners will analyze virus and host-specific parameters to enhance understanding of HBV control and facilitate patient stratification for future immunomodulatory therapies. Additionally, the registry will help identify hepatitis B patients interested in participating in upcoming studies focused on immunotherapies, such as therapeutic vaccines.
Who should consider this trial
Good fit: Ideal candidates for this registry are individuals with confirmed chronic hepatitis B virus infection who have been HBsAg positive for at least one year.
Not a fit: Patients over 70 years old or those with significant comorbidities or liver diseases may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved treatment strategies and better patient outcomes for those suffering from hepatitis B virus infections.
How similar studies have performed: Other studies have successfully utilized registries to improve understanding and treatment of chronic viral infections, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanover
- Hannover Medical School — Hanover, Germany (Recruiting)
Study contacts
- Principal investigator: Markus Cornberg — Hannover Medical School
- Study coordinator: Petra Dörge
- Email: doerge.petra@mh-hannover.de
- Phone: +49511532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.