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

NCT04672915 | Unknown

• 1 other identifier: HX202047
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

test of HBV DNA DIAGNOSTIC_TEST

Real time PCR or nested PCR to check

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population from the family with the history of CHB related cirrhosis or HCC.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an JiaotongUniversity

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yingren Zhao

  First Affiliated Hospital of Xian JiaotongUniversity

  STUDY DIRECTOR

Central Study Contacts

Yuan Yang

CONTACT

0086-029-85323262; xayangyuan@126.com

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 17, 2020
• Study Start: December 21, 2020
• Primary Completion: November 15, 2022
• Study Completion: December 30, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-08

Locations

CN (1)