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

NCT ID: NCT05483049

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-08-31

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

Detailed Description

Hepatitis B is caused by HBV infection, which can progress to chronic HBV infection after 6 months. HBV infection is a global public health problem, which can affect liver function and even threaten life health. HBV infection is worldwide prevalent, but the infection rate varies greatly in different regions. According to World Health Organization (WHO), there are about 257 million chronic HBV infections worldwide. The western Pacific region and Africa are the most prevalent regions of HBV, with the adult infection rate of 6.2% and 6.1% respectively. Most of Asia is a medium-high epidemic area 1. In 2014, Center for Disease Control and Prevention (CDC) conducted a serological epidemiological survey on hepatitis B among the population aged 1-29 in China, and the results showed that the prevalence rate of HBsAg in the population aged 1-4, 5-14 and 15-29 was 0.32%, 0.94% and 4.38%, respectively. It is estimated that the prevalence of HBsAg in the general population of China is 5-6%, and there are about 70 million chronic HBV infections, among which there are about 20-30 million chronic hepatitis B (CHB) patients. Chronic HBV infection increases the risk of liver fibrosis and hepatocellular carcinoma (HCC). The annual incidence of cirrhosis is 2-10% in CHB patients without antiviral therapy, and the annual incidence of HCC in patients with cirrhosis is 3-6%2.

The China 2019 Prevention and Treatment Guidelines of Chronic Hepatitis B recommend that patients with positive HBV DNA and elevated ALT, and those above 30 years old with family history of liver cirrhosis or HCC should initiate antiviral treatment, after ruling out other potential causes. However, the guideline did not identify the specific reference value of upper limit of normal for ALT, neither with cut off value of HBV detection. In addition, there is no clear definition of 'family history'. So, the fuzzy boundaries in the HBV guidelines may cause confusion when providing treatment recommendations in clinical practice and the value of this study would contribute to solve this kind of problems.

In a recently published study this year, 432 CHB patients who had liver biopsy in Ruijin Hospital during 2011-2017 were reviewed. So based on this, In the present study, we estimated a sample size of 600.Chronic HBV infected patients from 4 sites who underwent liver biopsy between 2008 and 2020.12 will be enrolled.

Previous studies have shown that a high proportion of HBV-infected patients with normal ALT have significant liver injury, including significant inflammation or fibrosis, and even cirrhosis.

And studies also show that treatment naive patients with normal ALT, either HBeAg-positive or HBeAg-negative, have a higher risk of developing HCC and even death than those in immune-active patients who received antiviral treatment (AVT). Therefore, early identification of patients with normal ALT but with significant liver inflammation or fibrosis is crucial.

Conditions

Chronic Hepatitis b

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

grey zone 1

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

No interventions assigned to this group

grey zone 2

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

WANG HUI

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Wang

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Central Contacts

Mingyang Feng

Role: CONTACT

fengmingyang1@163.com

+8619821371901

Other Identifiers

liver injury-grey zone

Identifier Type: -

Identifier Source: org_study_id