A Nomogram for Evaluating Significant Liver Fibrosis in Patients With Chronic Hepatitis B Virus Infection

Liver Fibrosis Clinical Trial

Official title:

Establish a New Noninvasive Diagnostic Model Based on Common Clinical Indicators to Evaluate the Liver Fibrosis in Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560503
• Other study ID #: 202205120
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 30, 2022

Study information

• Verified date: August 2022
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Liver fibrosis is the key step for progression to cirrhosis and liver cancer in patients with chronic hepatitis B (CHB). It is crucial to identify significant liver fibrosis in the treatment of CHB patients. Hence, the investigators aim to construct and validate a new nomogram model for evaluating significant liver fibrosis in CHB patients. The nomogram was based on a retrospective study of 259 CHB patients, who underwent liver biopsy. Through random grouping, 182 cases (70%) were included in the training set and 77 cases (30%) were included in the validation set. Biopsy pathological stage was used as the gold standard to screen the factors included in the model. The receiver operating characteristic (ROC), area under the ROC curve (AUC), calibration curve, and decision curve analysis were used to evaluate the diagnostic effect of this nomogram model. In addition, the investigators will compare the diagnostic efficiency of the new nomogram model with APRI, FIB-4, and GPR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: May 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• meet the diagnostic standard presented in Asian-Pacific clinical practice guidelines on the management of hepatitis B.
• HBsAg-positive for over 6 months.
• aged 18-65 years old.
• no gender limitation.

Exclusion Criteria:

• co-infection with other types of hepatitis viruses, including types A, C, D, and E.
• co-infection with human immunodeficiency virus (HIV).
• autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), inherited metabolic liver disease, drug-induced liver injury (DILI), alcoholic liver disease, and hepatocellular carcinoma (HCC).
• with other malignant tumor and other major systemic diseases.
• incomplete clinical data.

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis B
• Hepatitis B, Chronic
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in demographic data and clinical test indicators between significant liver fibrosis group and non-significant liver fibrosis group	Demographic data include age and sex. Dlinical test indicators include albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, ?-glutamyl transferase, alkaline phosphatase, white blood cell count, neutrophil count, hemoglobin, platelet count, prothrombin activity, international normalized ratio, activated partial thromboplastin time, alpha fetoprotein, HBV DNA, HBsAg, and HBeAg.	0 week