Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05678582
Other study ID # Soh-Med-22-12-26
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date July 15, 2023

Study information

Verified date July 2023
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date July 15, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Liver biopsy
liver biopsy were taken then evaluated by histopathological examination

Locations

Country Name City State
Egypt Faculty of medicine Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary degree of hepatic steatosis in CHB Mild, or Moderate or severe degree January 2023 to july 2023 will be included in the study
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01833611 - Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT Phase 4
Completed NCT00771446 - Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency Phase 1/Phase 2
Active, not recruiting NCT03731923 - Abbreviated MRI for HCC Surveillance N/A
Recruiting NCT03013556 - Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients Phase 4
Recruiting NCT05181826 - Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
Active, not recruiting NCT02143180 - Accuracy of RTE for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study N/A
Completed NCT00596414 - Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial Phase 4
Active, not recruiting NCT02772003 - DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection Phase 1
Terminated NCT04775797 - Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection Phase 1
Terminated NCT03487848 - Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection Phase 2
Recruiting NCT02822079 - DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection Phase 1
Recruiting NCT04446832 - VACcination of LIver Transplantation Candidates
Completed NCT01121705 - Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3) Phase 3
Completed NCT02742597 - Patient-Centred Innovations for Persons With Multimorbidity - Ontario N/A
Not yet recruiting NCT05062967 - Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
Completed NCT01380938 - Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE) Phase 3
Recruiting NCT01413360 - The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients Phase 4
Terminated NCT00496002 - Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus Phase 3
Terminated NCT00496158 - Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus Phase 3
Completed NCT02789800 - Patient-Centred Innovations for Persons With Multimorbidity - Quebec N/A