Prevalence of Occult Hepatitis B Virus Infection（OBI） in Subjects With Chronic Hepatitis B（CHB） Family History

Chronic Hepatitis b Clinical Trial

Official title:

Prevalence of Occult Hepatitis B Virus Infection（OBI） in Subjects With Chronic Hepatitis B (CHB） Family History and Cascading of Care Linked to Treatment in West China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672915
• Other study ID #: HX202047
• Status: Recruiting
• Start date: December 21, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yuan Yang
• Phone: 0086-029-85323262
• Email: xayangyuan[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mother to Child transmission is the main route of hepatitis B virus (HBV) transmission in China, attributing to over 50% HBV infection. Familial aggregation in HBV infection is well recognized with underlying stipulations like mother-to-child transmission（MTCT）, susceptible genes, close contact and other factors. Not surprisingly, a large proportion of hepatitis B virus infected population in China have a family history of hepatitis B virus infection. In clinical practice those family members usually undergo merely hepatitis B virus serology tests without HBV DNA test, which ruled out false HBsAg (-) or Occult HBV Infection (OBI) from Screening and linkage to care (SLTC). Unfortunately, the missed-out OBI in CHB family members was of a greater prevalence compared to those from general population (8.0% vs. 2.6%) . Moreover, OBI has been well recognized as strong risk factor in hepatocellular carcinoma （HCC） development with significant HBV DNA integration into host genome . In light of the latest 2019 China CHB guidelines, treatment criteria covered subjects with family history of CHB related cirrhosis or hepatocellular carcinoma(HCC). Therefore, subjects of HBsAg (+) with normal alanine aminotransferase（ALT） or OBI are eligible for further consideration of HBV anti-viral treatment.

This study proposed will explore the prevalence of OBI in subjects with family history of HBV related cirrhosis or HCC. The screened HBsAg (+) with normal alanine aminotransferase(ALT) and OBI subjects would be linked to anti-viral therapies.

Description:

Serum samples were tested for liver enzymes and liver synthesis function including ALT, aspartate aminotransferase（AST）, and albumin, etc. using a Hitachi 7600 automatic analyzer and reagent system (Hitachi, Tokyo, japan). HBsAg quantification was performed using automated electrochemiluminescence Immunoassay (ECLIA) manufactured by Roche. HBsAb, HBeAg, HBeAb and HBcAb were measured semi-quantitatively using Chemiluminescence Immunoassay (CLIA) manufactured by Abbott Diagnostics (USA). Serum HBV DNA levels were measured using the COBAS TaqMan HBV Monitor Test, with a lower limit of detection of 20 IU/mL (100 copies/mL).

The false negative result excluding OBI due to Real time PCR (lower limit of 20 IU/ml) technically may exist. The study group plan to carry out nested PCR (specifically target the HBV Pre-S, S, Pre-C/Core, and X open reading frames) on subjects with HBsAg (-) HBV DNA (-) and HBcAb(+) to double check the potential false negative result in HBV DNA from Real time PCR. Quantitation of intrahepatic HBV cccDNA by quantitative real-time PCR (qPCR).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First- and second-degree relatives of CHB patients in west China;

• Subjects with family history of CHB related cirrhosis or HCC;

• Subjects with ability to understand and sign a written informed consent form.

Exclusion Criteria:

• Positive antibody against hepatitis C virus(HCV),hepatitis D Virus(HDV), or human immunodeficiency virus(HIV) (anti-HCV, anti-HDV, or anti-HIV)

• Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease).

• Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers

• Non-hepatic cancer undergoing chemotherapy within last 6 months

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Herpesviridae Infections
• Virus Diseases

Intervention

Diagnostic Test:
• test of HBV DNA
Real time PCR or nested PCR to check

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an JiaotongUniversity	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of OBI in subjects with CHB family history	Serum samples were tested for liver enzymes and liver synthesis function including ALT, Aspartate aminotransferase(AST), and albumin, etc. using a Hitachi 7600 automatic analyzer.HBsAg quantification was performed using automated electrochemiluminescence Immunoassay (ECLIA) manufactured by Roche, with limit of detection at 0.05 IU/mL or confirmed by the HBsAg confirmatory assay ,with limit of detection at 0.005 IU/mL. HBsAb, HBeAg, HBeAb and HBcAb were measured semi-quantitatively using Chemiluminescence Immunoassay (CLIA) manufactured by Abbott Diagnostics (USA). Serum HBV DNA levels were measured using the COBAS TaqMan HBV Monitor Test, with a lower limit of detection of 20 IU/mL (100 copies/mL).	1 year