Clinical trial NCT06906016: New HBV Infection Biomarkers: Clinical Characterization and Impact on Management
Official title: New Biomarkers of HBV Infection: Clinico-Biological Characterization and Impact on Infection Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis B Virus (HBV) Infection
Keywords: Chronic Hepatitis B (HBV)
HBV RNA
HBV biomarkers
Hepatocellular carcinoma (HCC)
HBV genotyping
Hepatitis B treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients infected with HBV, followed in the hepatology department - Henri-Mondor University Hospital.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: HBsAg Seroconversion Rate
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of Biological Events
timeFrame: 1 year
measure: Quantification of VHB Transcripts
timeFrame: 1 year
measure: Biomarker Quantification: VHB RNA
timeFrame: 1 year
measure: Diagnosis of Liver Tumor
timeFrame: 1 year
measure: Incidence of Clinical Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Creteil
country: France
facility: Clinical Research Unit (CRU) Henri Mondor.
state: Créteil
Study officials:
References: