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

The European HBV Registry: A Joint Initiative of TherVacB and DZIF

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).

Study Overview

• Status: Recruiting
• Conditions: Hepatitis B Virus Infection
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Petra Dörge; Phone Number: 6057 +49511532; Email: doerge.petra@mh-hannover.de

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Recruiting
    • Hannover Medical School
    • Contact: Petra Dörge; Phone Number: 6057 +49511532; Email: doerge.petra@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients seen in day clinic or outpatient clinic at the participating study centers.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TherVacB Subgroup; 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.	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with change HBsAg levels	Regular assessment of quantitative HBsAg levels	5 years
Number of patients with seroconversion to anti-HBs	Measurement of quantitative HBsAg and anti-HBs levels	5 years
Quantification of IL6, IP-10, IFNg and IL1beta and correlation with HBsAg and ALT levels	Cytokine and Chemokine quantification in patients for subsequent correlation with viral parameters	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: European Union; German Center for Infection Research; German Liver Foundation (DLS)
• Investigators: Principal Investigator: Markus Cornberg, Hannover Medical School; Principal Investigator: Xavier Forns, Fundació Clínic Per A La Recerca Biomèdica

Publications and helpful links

Helpful Links

• Website of the EU funded part of the registry

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Infections; Hepatitis B; Hepatitis; Hepatitis A; Virus Diseases; Herpesviridae Infections
• Other Study ID Numbers: 3374-2016; 848223 (Other Grant/Funding Number: European Union); 05.220 (Other Grant/Funding Number: German Center for Infection Research (DZIF))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided which and where data will be shared. Depends on regulatory requirements of EU and German Federal Ministry of Education and Research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No