Ireland
--:--IST
Recruiting Observational

A Non-interventional Registry for Patients With Hepatitis B Virus Infection

NCT05051098 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2021-05-06
Last updated
2026-10-05

Condition(s) studied

Hepatitis B Virus Infection

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Hannover Medical School Hanover Germany Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05051098 on ClinicalTrials.gov ↗ ← All trials in Germany