The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06041022
Recruitment Status : Not yet recruiting
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
Sponsor:
Collaborators:
Linyi People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Wenzhou Medical University
Third Affiliated Hospital, Sun Yat-Sen University
Sir Run Run Shaw Hospital
First Affiliated Hospital of Zhejiang University
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Establishment and validation of the non-invasive model to predict antiviral therapy in the gray zone of chronic hepatitis B

Condition or disease Intervention/treatment
Hepatitis B, Chronic Other: Exposure factors

Detailed Description:
Chronic hepatitis B virus (HBV) infection continues to be a major public health problem worldwide today. According to statistics, the prevalence of chronic HBV infection assessed globally in 2016 was 3.5%, or 257 million people with chronic infection. In China, it is estimated that about 70 million people are chronically infected with HBV in 2019, including about 20-30 million people with chronic hepatitis B (CHB). CHB is a major risk factor for cirrhosis, and hepatocellular carcinoma (HCC). 12-20% of patients with chronic hepatitis B will develop cirrhosis, and of these, around 20% will further develop decompensated cirrhosis and 6-15% will develop HCC, with hepatitis B accounting for approximately 50% of HCC cases worldwide. Therefore, strongly and exact management of chronic hepatitis B is extremely important for the control of HBV progression. Current domestic and international clinical guidelines generally divide the natural history of chronic hepatitis B into four immune phases based on HBV DNA levels, liver injury, and HBeAg status: immune active, immune tolerant, inactive HBsAg carriers, and reactive stage. The guidelines of American Association for the Study of Liver Diseases (AASLD) recommend the use of antiviral therapy for patients in the immune active and reactive phases, and also provide a detailed follow-up plan for patients in other phases. However, a significant number of patients with chronic hepatitis B cannot be classified in any of these four phases, who falls into a gray area with uncertainty of formal management. According to the 2018 AASLD Hepatitis B Guidelines criteria for antiviral therapy, patients in the gray zone still do not have clarity on the need for antiviral therapy based only on clinical indicators. A recent study showed that nearly 40% of patients with chronic hepatitis B were in the indeterminate stage. At long-term follow-up assessment, half of these patients were still in the indeterminate phase and one-fifth had transitioned to the immune active phase. Patients in the indeterminate phase were 14 times more likely to develop HCC than those with inactive hepatitis B. Therefore, the management of antiviral therapy in patients with CHB in the "gray zone" is crucial and should be demonstrated. The aim of the investigators is to investigate the clinical characteristics of patients with uncertain treatment in the "gray zone" of CHB and to develop a non-invasive predictive model for the indication of antiviral therapy. This will provide guidance for the clinical management of patients in the "gray zone" of CHB, thereby reducing the incidence of cirrhosis and liver cancer and improving their quality of life.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Non-invasive Model to Predict Antiviral Therapy in Patients With Gray Zone of Chronic Hepatitis B: a Multi-center, Retrospective Study
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: Exposure factors
    Including demographical data, laboratory features and liver histological indicators.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with the antiviral therapy as assessed by AASLD guideline [ Time Frame: From Jan 1st,2010 to Aug 31,2023 ]

    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.

  2. Number of participants with significant liver histology as assessed by Metavia scoring system [ Time Frame: From Jan 1st,2010 to Aug 31,2023 ]

    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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041022


Contacts
Layout table for location contacts
Contact: Yu-Chen Fan, MD,PhD 18560082065 fanyuchen@sdu.edu.cn

Sponsors and Collaborators
Qilu Hospital of Shandong University
Linyi People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Wenzhou Medical University
Third Affiliated Hospital, Sun Yat-Sen University
Sir Run Run Shaw Hospital
First Affiliated Hospital of Zhejiang University
Investigators
Layout table for investigator information
Study Chair: Yu-Chen Fan, MD,PhD Qilu Hospital of Shandong University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT06041022    
Other Study ID Numbers: KYLL-202301-030
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qilu Hospital of Shandong University:
Antiviral therapy
Liver biopsy
Gray zone
Model
Chronic hepatitis B
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Chronic Disease
Disease Attributes
Pathologic Processes