| CTRI Number |
CTRI/2025/09/095286 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Diagnostic accuracy of HBcrAg biomarker in comparison to HBV DNA PCR in Hepatitis B infetcted patients. |
|
Scientific Title of Study
|
Evaluation of Hepatitis B core related antigen (HBcrAg)
Immunoassay in Chronic Hepatitis B infected cases |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ekta Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Clinical Virology, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi
New Delhi
DELHI
110070
India |
| Phone |
9899975974 |
| Fax |
|
| Email |
ektagaurisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ekta Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Clinical Virology, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi
New Delhi
DELHI
110070
India |
| Phone |
9899975974 |
| Fax |
|
| Email |
ektagaurisha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ekta Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Clinical Virology, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi
New Delhi
DELHI
110070
India |
| Phone |
9899975974 |
| Fax |
|
| Email |
ektagaurisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Agappe Diagnostics Limited, Agappe Hills, Pattimattom P O, Ernakulam, Kerala, India, Pincode - 683562 |
|
|
Primary Sponsor
|
| Name |
Agappe Diagnostics Limited |
| Address |
Agappe Hills, Patimattom P O, Ernakulam, Kerala, India, Pincode - 683562 |
| Type of Sponsor |
Other [IVD Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ekta Gupta |
Institute of Liver and Biliary Sciences |
Department of Clinical Virology, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi
New Delhi
DELHI |
09899975974
ektagaurisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Liver and Biliary Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B189||Chronic viral hepatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HBcrAg biomarker quantitation. |
HBcrAg protein quantification using Chemiluminescence enzyme immunoassay. Duration of the intervention-6 months. |
| Comparator Agent |
HBV DNA RT PCR as the comparator. |
HBcrAg biomarker quantitation in reference to HBV DNA RT PCR. Duration of the intervention-6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy confirmation of HBcrAg biomarker in comparison to HBV DNA real time PCR. |
6 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |