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

NCT05051098 | Recruiting

• 3 other identifiers: 3374-201684822305.220
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatitis B Virus Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Number of patients with hepatitis B related increased or decreased quality of life

  5 years

• Number of patients with hepatitis B related HCC (hepatocellular carcinoma)

  5 years

• Number of patients with hepatitis B related liver cirrhosis

  5 years

• Number of patients with hepatitis B related death

  5 years

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

TherVacB Subgroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Hepatitis B Virus Infection
• TherVacB sub-cohort:
• HBeAg status documented for at least 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• European Union: collaborator
• German Center for Infection Research: collaborator
• German Liver Foundation (DLS): collaborator

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Related Links

• Website of the EU funded part of the registry

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Markus Cornberg

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

• Xavier Forns

  Fundacio Clinic per a la Recerca Biomedica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Dörge

CONTACT

+49511532; doerge.petra@mh-hannover.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 21, 2021
• Study Start: May 6, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

DE (1)