Prevalence of Significant Liver Fibrosis and Inflammation in Chronic HBV Infected Patients in Grey Zone

NCT05483049 | Unknown

• 1 other identifier: liver injury-grey zone
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore whether normal alanine aminotransferase (ALT) is associated with liver injury in a cohort of hepatitis B virus (HBV) infected patients in grey zone

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (2)

• Prevalence of significant liver fibrosis.

  Prevalence of significant liver fibrosis (G≥2) in patients in all patients.

  from Jan, 2008 to December, 2021

• Prevalence of significant liver inflammation.

  Prevalence of significant liver inflammation (S≥2) in patients in all patients.

  from Jan, 2008 to December, 2021

Secondary Outcomes (16)

• Prevalence of significant liver fibrosis in different age group in grey zone 1.

  from Jan, 2008 to December, 2021

• Prevalence of significant liver inflammation in different age group in grey zone 1.

  from Jan, 2008 to December, 2021

• Prevalence of significant liver fibrosis in different age group in grey zone 2.

  from Jan, 2008 to December, 2021

• Prevalence of significant liver inflammation in different age group in grey zone 2.

  from Jan, 2008 to December, 2021

• Prevalence of significant liver fibrosis at different ALT level in grey zone 1.

  from Jan, 2008 to December, 2021

Study Arms (2)

grey zone 1

HBeAg (+), HBV DNA \>20 but \< 10000000IU/mL, ALT ≤40 U/L

grey zone 2

HBeAg (-), HBV DNA \> 2000 IU/mL, ALT ≤40 U/L

Eligibility Criteria

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

Study Population

An estimated 600 chronic HBV infected patients who underwent liver biopsy between Jan, 2008 and December, 2021 will be enrolled.

You may qualify if:

• Treatment naïve
• serum HBsAg positive for \>6 months
• Grey zone 1: HBeAg (+), HBV DNA \>20 but \< 107IU/mL, ALT ≤40 U/L
• Grey zone 2: HBeAg (-), HBV DNA \> 2000 IU/mL, ALT ≤40 U/L

You may not qualify if:

• Co-infection with HCV, HDV or HIV
• decompensated cirrhosis
• other chronic liver diseases

Sponsors & Collaborators

• Ruijin Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

liver biopsy

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

• Hui Wang

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyang Feng

CONTACT

+8619821371901; fengmingyang1@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 1, 2022
• Study Start: September 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share