Evaluation of Hepatitis B core related antigen (HBcrAg) Immunoassay in Chronic Hepatitis B infected cases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy confirmation of HBcrAg biomarker in comparison to HBV DNA real time PCR.
研究概览
简要总结
Chronic Hepatitis B (CHB) remains a significant global health concern, affecting over 254
million individuals worldwide and contributing to serious complications such as hepatic fibrosis,
cirrhosis, and hepatocellular carcinoma (HCC). Traditional serological and virological markers,
including HBsAg, HBeAg, and HBV DNA, play essential roles in diagnosis and monitoring but have
limited capacity to accurately reflect intrahepatic viral replication and covalently closed circular DNA
(cccDNA) activity.
There is an increasing need for novel, non-invasive biomarkers that can better assess the replicative
status of HBV, predict treatment response, and identify early risk of reactivation. Among these,
Hepatitis B core-related antigen (HBcrAg) has emerged as a promising candidate. Comprising
HBcAg, HBeAg, and a 22-kDa core-related protein (p22cr), HBcrAg reflects transcriptional activity
from the cccDNA minichromosome. Studies have shown that serum HBcrAg levels fluctuate across
different phases of CHB, correlate better with intrahepatic cccDNA than quantitative HBsAg, and serve
as better predictors of HBeAg seroconversion and treatment cessation.
Despite its clinical utility being recognized globally, no Indian studies have yet evaluated HBcrAg in
the context of CHB management.There are no commercially available kits or instruments for
this biomarker detection.TheMISPA i60 HBcrAg is a chemiluminescent enzyme immunoassay (CLEIA) that
uses chemiluminescent substrate (AMPPD) for measurement.This has recently been launched in Japan
and is used extensively globally. This kit or instrument is launched in India for the first time. The present
study aims to evaluate the diagnostic performance of MISPA i60 HBcrAg CLEIA assay for
quantitative detection of HBcrAg in clinical samples from CHB infected cases and to compare it with
traditional virological markers such as quantitative HBsAg and HBV DNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Study group (n=250): Adult population (Above 18 years) diagnosed with CHB (HBsAg and /or HBV DNA positive for more than 6 months or histopathologically confirmed chronic hepatitis with HBsAg positive), both treatment naïve and experienced in different groups in which adequate specimen volume (minimum 1 ml) could be retrieved.
- •Control group (n=50): True negative which is defined as virologically confirmed Hepatitis B negative cases (HBsAg negative and or anti-HBcore total negative and or HBV DNA negative), adult population (above 18 years) in which adequate specimen volume (minimum 1 ml) could be retrieved.
排除标准
- •Co-infection with other hepatotropic virus (Hepatitis A/C/D/E) Cases with underlying other chronic liver disease Co-infection with HIV Patients on other immunosuppressive therapy Pregnant females.
结局指标
主要结局
Diagnostic accuracy confirmation of HBcrAg biomarker in comparison to HBV DNA real time PCR.
时间窗: 6 months
次要结局
未报告次要终点
研究者
Dr Ekta Gupta
Institute of Liver and Biliary Sciences