Hepatic Steatosis and Chronic Hepatitis B Virus

NCT ID: NCT05678582

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-07-15

Brief Summary

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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

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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

Conditions

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Chronic Hepatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HBV with hepatic steatosis

HBV with hepatic steatosis on liver biopsy

Liver biopsy

Intervention Type DIAGNOSTIC_TEST

liver biopsy were taken then evaluated by histopathological examination

HBV without hepatic steatosis

HBV without hepatic steatosis on liver biopsy

Liver biopsy

Intervention Type DIAGNOSTIC_TEST

liver biopsy were taken then evaluated by histopathological examination

Interventions

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Liver biopsy

liver biopsy were taken then evaluated by histopathological examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mona Mohammed Abdelrhman

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nagwa Sadek, MD

Role: STUDY_CHAIR

Sohag University

Locations

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Faculty of medicine

Sohag, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 26707365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28427875 (View on PubMed)

Other Identifiers

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Soh-Med-22-12-26

Identifier Type: -

Identifier Source: org_study_id

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