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

Recruiting

• Conditions: Hepatitis B Virus Infection
• Interventions: Other: No intervention

• Registration Number: NCT05051098
• Lead Sponsor: Hannover Medical School

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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-06
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TherVacB Subgroup	No intervention	No interventions. The participating study centers of the EU funded project "TherVacB" recruit patients with stricter inclusion- and exclusion criteria, hence forming a sub-cohort.

Primary Outcome Measures

Name	Time	Method
Number of patients with seroconversion to anti-HBs	5 years	Measurement of quantitative HBsAg and anti-HBs levels
Number of patients with change HBsAg levels	5 years	Regular assessment of quantitative HBsAg 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

Secondary Outcome Measures

Name	Time	Method
Number of patients with hepatitis B related liver cirrhosis	5 years	Regular assessment of liver status
Number of patients with hepatitis B related death	5 years	Regular quantification of lost-to-follow-up reasons.
Number of patients with hepatitis B related increased or decreased quality of life	5 years	Regular assessment of QOL by SF36 questionnaires.
Number of patients with hepatitis B related HCC (hepatocellular carcinoma)	5 years	Regular assessment of HCC status

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany