Hepatic Steatosis and Chronic Hepatitis B Virus

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

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Key information

Conditions

Chronic Hepatitis Chronic Disease Digestive System Diseases Disease Attributes Fatty Liver Hepatitis Hepatitis, Chronic Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine

Sohag, 82524, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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/mm3.

Treatment and study plan

Liver biopsy

Diagnostic Test

liver biopsy were taken then evaluated by histopathological examination

Primary outcomes

prevalence of hepatic steatosis in CHB

Time frame: 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

Time frame: January 2023 to july 2023 will be included in the study

Mild, or Moderate or severe degree

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

The Impact of Hepatic Steatosis on Chronic Hepatitis B Virus Infection

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jan 10, 2023
Registry last updated: Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed