A Non-invasive Model to Predict Antiviral Therapy in Gray Zone of Chronic Hepatitis B

NCT06041022 | Unknown

• 1 other identifier: KYLL-202301-030
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Establishment and validation of the non-invasive model to predict antiviral therapy in the gray zone of chronic hepatitis B

Conditions

Hepatitis B, Chronic

Keywords

Antiviral therapy; Liver biopsy; Gray zone; Model; Chronic hepatitis B

Outcome Measures

Primary Outcomes (2)

• Number of participants with the antiviral therapy as assessed by AASLD guideline

  The criteria of antiviral therapy: 1. Immune-active CHB: an elevation of ALT≥2 the upper limit of normal (ULN)plus elevated HBV DNA above 2,000 IU/mL (HBeAg negative) or above 20,000 IU/mL (HBeAg positive). 2. Immune-active CHB and cirrhosis if HBV DNA is \>2,000 IU/mL. 3. Immune-active CHB with ALT \< 2 the ULN and HBV DNA below thresholds (less than 2,000 IU/mL if HBeAg negative or less than 20,000 IU/mL if HBeAg positive) are as follows: 1) Age: older age (\>40 years). 2) Family history of cirrhosis or HCC. 3) Previous treatment history. 4) Presence of extrahepatic manifestations. 5) Presence of cirrhosis. 4. Immune tolerance CHB with the moderate-to-severe necroinflammation or fibrosis on a liver biopsy specimen.

  From Jan 1st,2010 to Aug 31,2023

• Number of participants with significant liver histology as assessed by Metavia scoring system

  Significant liver histology showing significant hepatic inflammation ≥G2 and/or fibrosis ≥S2 as assessed by Metavir scoring system The fibrosis score is used to describe the amount of inflammation (the intensity of inflammation/breakdown of tissue) in the liver: F0: No fibrosis F1: Portal fibrosis without septa F2: Portal fibrosis with few septa F3: Numerous septa without cirrhosis F4: Cirrhosis The activity score is a prediction about how rapidly the degree of fibrosis is progressing: G0: No activity G1: Mild activity G2: Moderate activity G3: Severe activity

  From Jan 1st,2010 to Aug 31,2023

Interventions

Exposure factors OTHER

Including demographical data, laboratory features and liver histological indicators.

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The minimum sample size required for the study was calculated to be 417, and it was estimated that almost 1000 patients with chronic hepatitis B underwent hepatic puncture biopsy in the seven hospitals from 2010 to 2022, and all patients will be included in the study.

You may qualify if:

• HBeAg positive, normal serum alanine aminotransferase(ALT) level，HBVDNA≤10\^6 IU/ml
• HBeAg positive, elevated serum ALT, HBVDNA≤2\*10\^4 IU/ml
• HBeAg negative, elevated serum ALT, HBVDNA≤2\*10\^3 IU/ml
• HBeAg negative, normal serum ALT, HBVDNA≥2\*10\^3 IU/ml
• Normal upper limit of ALT is 35 U/L for male and 25 U/L for female.

You may not qualify if:

• Concurrent with other liver diseases such as autoimmune hepatitis, Hepatitis C virus infectious, liver cirrhosis, HCC, or unexplained liver function abnormalities
• Patients with incomplete clinical data

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Linyi People's Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator

Related Publications (6)

• Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28.

  PMID: 26231459 BACKGROUND

• Wang G, Duan Z. Guidelines for Prevention and Treatment of Chronic Hepatitis B. J Clin Transl Hepatol. 2021 Oct 28;9(5):769-791. doi: 10.14218/JCTH.2021.00209. Epub 2021 Sep 28.

  PMID: 34722192 BACKGROUND

• Huang DQ, Lim SG. Hepatitis B: Who to treat? A critical review of international guidelines. Liver Int. 2020 Feb;40 Suppl 1:5-14. doi: 10.1111/liv.14365.

  PMID: 32077616 BACKGROUND

• Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.

  PMID: 29405329 BACKGROUND

• Ma HY, Yang XY, Tian YX, Li XD, He YL, Yang Q, Zheng MH, Zheng YB, Yu Y, Xu LY, Wang QN, Zhang T, Shi Y, Fan YC. Performance of the AASLD, EASL, and APASL Clinical Practice Guidelines in"grey zone"stages of Chinese patients with chronic hepatitis B. Hepatol Int. 2025 Aug;19(4):796-808. doi: 10.1007/s12072-025-10833-3. Epub 2025 May 14.

  PMID: 40360826 DERIVED

• Yang XY, Li XD, Wu BY, Yang Q, Zheng YB, Zheng MH, Wu YP, Ma HY, Zuo J, Jia RX, Yu Y, Xu LY, Tian YX, An Q, Zhang T, He YL, Shi Y, Fan YC. A Model to Identify Gray Zone Patients With Chronic Hepatitis B Requiring Antiviral Therapy: A Multicenter Retrospective Study. J Infect Dis. 2025 Aug 14;232(2):485-498. doi: 10.1093/infdis/jiaf070.

  PMID: 39960318 DERIVED

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

• Yu-Chen Fan, MD,PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Yu-Chen Fan, MD,PhD

CONTACT

18560082065; fanyuchen@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 18, 2023
• Study Start: October 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 31, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share