New HBV Infection Biomarkers: Clinical Characterization and Impact on Management
HBV-Biomark
New Biomarkers of HBV Infection: Clinico-Biological Characterization and Impact on Infection Management
1 other identifier
observational
900
1 country
1
Brief Summary
Chronic Hepatitis B Virus (HBV) infection affects nearly 300 million people worldwide and is a leading cause of liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). In France, it affects around 0.3% of the population. Current clinical practice relies on traditional biomarkers, such as HBV DNA and HBsAg, to monitor viral replication and disease progression. However, these biomarkers do not fully capture the viral activity or predict clinical outcomes. Recently, new biomarkers like HBcrAg and HBV RNA have emerged, showing promise for better understanding the natural history of the infection and guiding treatment decisions. The main objective of this research is to evaluate the predictive role of these biomarkers (HBcrAg, HBV RNA) in HBV-infected patients, focusing on their association with HBsAg seroconversion and their ability to predict clinical events like cirrhosis and HCC. Secondary objectives include describing the clinicobiological characteristics of patients, determining HBV genotypes, characterizing the impact of HBV on the host's transcriptome, and studying the biomarkers' role in different phases of the infection and treatment. The ultimate goal is to identify more accurate biomarkers to guide antiviral treatment, predict disease progression, and potentially determine when treatment can be safely discontinued.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2023
CompletedFirst Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 27, 2038
April 2, 2025
March 1, 2025
15 years
March 4, 2025
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBsAg Seroconversion Rate
Defined by the absence of detectable AgHBs in the serum using ELISA test
3 months
Secondary Outcomes (5)
Incidence of Biological Events
1 year
Quantification of VHB Transcripts
1 year
Biomarker Quantification: VHB RNA
1 year
Diagnosis of Liver Tumor
1 year
Incidence of Clinical Events
1 year
Study Arms (1)
Cohort Study on Chronic HBV Infection
This study is a cohort study. It follows a group of patients infected with HBV (Hepatitis B) over an extended period to evaluate the predictive role of biomarkers in the progression of the infection and the response to antiviral treatment. Patients are monitored over time, with regular sample collection to measure biomarkers and assess clinical and biological events, such as seroconversion or the emergence of complications like cirrhosis or liver cancer.
Interventions
The intervention involves the additional and minimal collection of two blood samples during routine care procedures (9mL in a dry tube and 9mL in a Paxgene tube). These samples are specifically collected for research purposes and will be stored in the laboratory at the Henri Mondor Biobank Platform under the responsibility of Pr Bijan Ghaleh-Marzban for 15 years. The samples will be preserved under strict conditions and may be used for future analyses related to the pathology of HBV infection or other scientific advancements, with the patient's informed consent.
Eligibility Criteria
Patients infected with HBV, followed in the hepatology department - Henri-Mondor University Hospital.
You may qualify if:
- years old
- Chronic HBV infection (HbsAg positive carrier for more than 6 months)
- Patient under care within the Henri Mondor-Albert Chenevier University Hospital group
You may not qualify if:
- History of liver transplantation for liver failure in the context of chronic HBV infection
- Protected adults, adults unable to express their consent
- Pregnant or breastfeeding women
- Person not affiliated with a Social Security system
- Patient refusal to participate in the project
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Unit (CRU) Henri Mondor.
Créteil, Créteil, 94000, France
Biospecimen
Blood samples: Collected during the regular medical consultations of the patients. These samples will be used to assess various biomarkers associated with the HBV infection. Research-specific samples: 9 mL of dry tube (serum): This sample will be used for analyzing various biomarkers, including the quantification of viral RNA, and assessing other clinical markers of HBV infection. 9 mL Paxgene tube: This sample will be used for RNA extraction, which is crucial for studying the virus's RNA (HBV RNA) and its role in viral replication, as well as other potential molecular characteristics.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2025
First Posted
April 2, 2025
Study Start
November 28, 2023
Primary Completion (Estimated)
November 27, 2038
Study Completion (Estimated)
November 27, 2038
Last Updated
April 2, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION