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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.
This study focuses on the chronic Hepatitis B virus (HBV) infection, which affects nearly 300 million people globally, leading to cirrhosis, hepatocellular carcinoma (HCC), and other severe liver diseases. The objective is to evaluate new biomarkers for HBV infection, specifically HBV core-related antigen (HBcrAg) and HBV RNA, and their potential role in the clinical management and prognosis of the disease. Traditional biomarkers used to track viral replication and liver fibrosis, such as HBV DNA, HBeAg, and HBsAg, have limitations, which this study aims to address by exploring emerging biomarkers that could improve the understanding of the infection's natural history and response to antiviral treatments.
The population involved in the study includes patients diagnosed with chronic HBV infection and receiving care at Henri Mondor-Albert Chenevier University Hospital. Patients must be 18 years or older and have been infected with HBV (positive HBsAg for more than six months). Exclusion criteria include individuals with liver transplantation history, those unable to provide consent, pregnant or breastfeeding women, and those not affiliated with a Social Security scheme.
The study design includes both primary and secondary evaluation criteria. The primary criterion is the incidence of HBsAg seroconversion (absence of detectable HBsAg in serum). Secondary criteria include the proportion of patients positive for HBeAg, the incidence of clinical events like cirrhosis and HCC, and the molecular characterization of HBV, such as genotype distribution and the presence of co-infections like hepatitis C (HCV) or HIV. Other secondary criteria also include the measurement of liver fibrosis using Fibroscan and screening for HCC through abdominal ultrasound and alpha-fetoprotein (AFP) tests.
Research procedures involve routine medical consultations, with additional blood samples (9mL dry tube and 9mL Paxgene) collected for research purposes once a year. Patients will be followed for a period of 10 years, with regular monitoring of HBV biomarkers and liver status to evaluate the progression of the infection, the risk of developing liver disease, and the potential predictive value of new biomarkers for viral replication and clinical outcomes. The ultimate aim is to enhance HBV management by identifying predictive biomarkers and refining treatment strategies, particularly to optimize antiviral therapies and improve patient prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of blood samples for the study of HBV biomarkers | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg Seroconversion Rate | Defined by the absence of detectable AgHBs in the serum using ELISA test | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Biological Events | Monitoring the seroconversion of HBeAg using biological data, measured by the proportion of patients with HBeAg seroconversion. | 1 year |
| Quantification of VHB Transcripts |
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Inclusion Criteria:
Exclusion Criteria:
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Patients infected with HBV, followed in the hepatology department - Henri-Mondor University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent LEROY, Dr | Contact | +33 0149812325 | vincent.leroy2@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit (CRU) Henri Mondor. | Recruiting | Créteil | Créteil | 94000 | France |
DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D007239 | Infections |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
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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.
|
Quantitative analysis of VHB transcripts using PCR, measured in copies per milliliter (copies/ml).
| 1 year |
| Biomarker Quantification: VHB RNA | Quantification of the virus biomarker VHB RNA during follow-up using PCR, measured in copies per milliliter (copies/ml). | 1 year |
| Diagnosis of Liver Tumor | Diagnostic assessment of liver tumors using medical imaging techniques, such as MRI | 1 year |
| Incidence of Clinical Events | Monitoring of clinical events, such as cirrhosis, measured by the proportion of patients affected by clinical events. | 1 year |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |