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Hepatic Steatosis and Chronic Hepatitis B Virus

S

Sohag University

Status

Completed

Conditions

Chronic Hepatitis

Treatments

Diagnostic Test: Liver biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT05678582
Soh-Med-22-12-26

Details and patient eligibility

About

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

Full 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

Enrollment

91 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

91 participants in 2 patient groups

HBV with hepatic steatosis
Description:
HBV with hepatic steatosis on liver biopsy
Treatment:
Diagnostic Test: Liver biopsy
HBV without hepatic steatosis
Description:
HBV without hepatic steatosis on liver biopsy
Treatment:
Diagnostic Test: Liver biopsy

Trial contacts and locations

1

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Central trial contact

Amira Maher, MD; Mona Abdelrahmam, MD

Data sourced from clinicaltrials.gov

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