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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05051098
Other study ID # 3374-2016
Secondary ID 84822305.220
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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