Hepatic Steatosis and Chronic Hepatitis B Virus

NCT05678582 | Completed DMC

• 1 other identifier: Soh-Med-22-12-26
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis

Keywords

HBV; Steatosis

Outcome Measures

Primary Outcomes (2)

• prevalence of hepatic steatosis in CHB

  Number of cases with hepatic steotosis in CHB

  January 2023 to july 2023 will be included in the study

• degree of hepatic steatosis in CHB

  Mild, or Moderate or severe degree

  January 2023 to july 2023 will be included in the study

Study Arms (2)

HBV with hepatic steatosis

HBV with hepatic steatosis on liver biopsy

Diagnostic Test: Liver biopsy

HBV without hepatic steatosis

HBV without hepatic steatosis on liver biopsy

Diagnostic Test: Liver biopsy

Interventions

Liver biopsy DIAGNOSTIC_TEST

liver biopsy were taken then evaluated by histopathological examination

HBV with hepatic steatosis; HBV without hepatic steatosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine

Sohag, 82524, Egypt

Location

Related Publications (2)

• Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.

  PMID: 26707365 BACKGROUND

• European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.

  PMID: 28427875 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ultrasound-guided percutaneous liver biopsy

MeSH Terms

Conditions

Hepatitis, Chronic; Fatty Liver

Condition Hierarchy (Ancestors)

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

Study Officials

• Nagwa Sadek, MD

  Sohag University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 15, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)