A Non-interventional Registry for Patients with Hepatitis B Virus Infection
Recruiting · NCT05051098 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hannover Medical School
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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 it is running
1 location listed.
- Hannover Medical School - Hanover, Germany