Hepatic Steatosis and Chronic Hepatitis B Virus

Completed

• Conditions: Chronic Hepatitis
• Interventions: Diagnostic Test: Liver biopsy

• Registration Number: NCT05678582
• Lead Sponsor: Sohag University

Brief Summary

This study aims to evaluate the prevalence and severity of hepatic steatosis in CHB and investigate the relationship between hepatic steatosis and viral load, liver biochemistry, liver fibrosis, and inflammation in CHB

Detailed Description

This hospital-based cohort study will be conducted on 80 adult hepatitis B surface antigen (HBsAg) carriers presented to the Tropical Medicine and Gastroenterology outpatient clinic, at Sohag University Hospital Exclusion criteria Patients with serological evidence of HCV. HBV patients who had received or are currently under anti-viral therapy. Alcohol consumption. Decompensated liver disease. Patients with HCC. Patients are known to have another chronic liver disease (e.g. autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, Haemochromatosis, or drug-induced chronic hepatitis).

Patients with contraindications to liver biopsy such as uncooperative patients, prothrombin time (PT) \>4 seconds more than control, INR greater than 1.6, platelets count \<100.000/mm3After taking informed written consent, the participants will be subjected to:

Clinical evaluation: medical history and physical examination.

Laboratory investigations:

Complete blood count. Prothrombin time and concentration. Liver function tests Anti-HCV. HBeAg. HBV DNA. Abdominal ultrasonography Ultrasound-guided percutaneous liver biopsy

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-28
• Study Start: 2023-01-01
• Study First Posted: 2023-01-10
• Primary Completion: 2023-06-30
• Status Verified: 2023-07
• Study Completion: 2023-07-15
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Hepatitis B surface antigen (HBsAg) carriers presented to the Tropical Medicine and Gastroenterology outpatient clinic, at Sohag University Hospital

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Exclusion Criteria

Patients with serological evidence of HCV. HBV patients who had received or are currently under anti-viral therapy. Alcohol consumption. Decompensated liver disease. Patients with HCC. Patients are known to have another chronic liver disease (e.g. autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, Haemochromatosis, or drug-induced chronic hepatitis).

Patients with contraindications to liver biopsy such as uncooperative patients, prothrombin time (PT) >4 seconds more than control, INR greater than 1.6, platelets count <100.000/mm3.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBV without hepatic steatosis	Liver biopsy	HBV without hepatic steatosis on liver biopsy
HBV with hepatic steatosis	Liver biopsy	HBV with hepatic steatosis on liver biopsy

Primary Outcome Measures

Name	Time	Method
prevalence of hepatic steatosis in CHB	January 2023 to july 2023 will be included in the study	Number of cases with hepatic steotosis in CHB
degree of hepatic steatosis in CHB	January 2023 to july 2023 will be included in the study	Mild, or Moderate or severe degree

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Sohag, Egypt