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

Hepatitis B Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051098
• Other study ID #: 3374-2016
• Secondary ID: 84822305.220
• Status: Recruiting
• Start date: May 6, 2021
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Hannover Medical School
• Contact: Petra Dörge
• Phone: +49511532
• Email: doerge.petra[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus Infection
• Herpesviridae Infections
• Infections
• Virus Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (4)

Lead Sponsor	Collaborator
Hannover Medical School	European Union, German Center for Infection Research, German Liver Foundation (DLS)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with change HBsAg levels	Regular assessment of quantitative HBsAg levels	5 years
Primary	Number of patients with seroconversion to anti-HBs	Measurement of quantitative HBsAg and anti-HBs levels	5 years
Primary	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	Number of patients with hepatitis B related increased or decreased quality of life	Regular assessment of QOL by SF36 questionnaires.	5 years
Secondary	Number of patients with hepatitis B related HCC (hepatocellular carcinoma)	Regular assessment of HCC status	5 years
Secondary	Number of patients with hepatitis B related liver cirrhosis	Regular assessment of liver status	5 years
Secondary	Number of patients with hepatitis B related death	Regular quantification of lost-to-follow-up reasons.	5 years

External Links

•   Website of the EU funded part of the registry