Liver Status and Presence of MASLD/MASH in Patients With Chronic Hepatitis B

NCT06573190 | Completed

• 1 other identifier: Guven Health Group Faraday
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to evaluate the consistency between liver biopsy and Liver Stiffness Measurement (LSM) for fibrosis and controlled attenuation parameter (CAP) for steatosis in FibroScan® in patients with chronic hepatitis B. The secondary aim of the study was to demonstrate the efficacy of FibroScan® for following the CHB patients at 12th month of antiviral therapy. The study was prospectively planned in four different centers. Patients with HBsAg positivity for more than six months and HBV-DNA\>2,000 IU/mL, underwent liver biopsy and FibroScan® together within two week. FibroScan® was performed twice, before the antiviral therapy and one year later.

Conditions

Chronic Hepatitis B; Hepatic Steatosis

Keywords

Chronic hepatitis B; Metabolic syndrome; Hepatic fibrosis; Hepatic steatosis

Outcome Measures

Primary Outcomes (4)

• Histological activity index (HAI) evaluatin by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy.

  All patients underwent liver biopsy before initiating antiviral therapy, for evaluating histological activity index (HAI). According to modified HAI system (Ishak), HAI scores ranging from 0 to 18 were used.

  23.01.2023-25.04.2023

• Fibrosis score evaluation by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy.

  All patients underwent liver biopsy before initiating antiviral therapy, for evaluating fibrosis score. According to modified HAI system (Ishak), seven point scale ranging from 0 to 6 for fibrosis stage.

  23.01.2023-25.04.2023

• Hepatic steatosis evaluation by Controlled Attenuation Parameter (CAP) on FibroScan® in patients with chronic hepatitis B before initiating antiviral therapy.

  FibroScan® measurements were perfomred at most two weeks apart from biopsy. Hepatic steatosis by Controlled Attenuation Parameter (CAP) were investigated on FibroScan® for MASLD and MASH. Obese or diabetic patients with a CAP value \>240 dB/m were considered MASLD. Patients with normal BMI and nondiabetic patients had at least two risk factors for metabolic dysfunction were also considered to have MASLD.

  23.01.2023-25.04.2023

• Fibrosis stage by Liver Stiffness Measurement (LSM) on FibroScan® in patients with chronic hepatitis B before initiating antiviral therapy.

  FibroScan® measurements were perfomred at most two weeks apart from biopsy. Fibrosis stage by Liver Stiffness Measurement (LSM) was investigated on FibroScan®. Necroinflammation was considered as LSM ≥7.2 kPa in patients with MASLD. Patients with MASLD and concomitant necroinflammation in the liver were considered as MASH.

  23.01.2023-25.04.2023

Secondary Outcomes (2)

• Hepatic steatosis evaluation by Controlled Attenuation Parameter (CAP) on FibroScan® in patients with chronic hepatitis B at 12th month of antiviral therapy.

  23.01.2024-25.04.2024

• Fibrosis stage by Liver Stiffness Measurement (LSM) on FibroScan® in patients with chronic hepatitis B.

  23.01.2024-25.04.2024

Study Arms (1)

Chronic hepatitis B patients

Patients aged 18 years and older with HBsAg positivity for more than six months and HBV-DNA level \>2,000 IU/ml

Diagnostic Test: Transient elastography; Drug: Tenofovir Disoproxil Fumarate

Interventions

Transient elastography DIAGNOSTIC_TEST

Liver Stiffness Measurement, Controlled Attenuation Parameter

Also known as: Fibroscan

Chronic hepatitis B patients

Tenofovir Disoproxil Fumarate DRUG

Guided Therapy

Also known as: TDF

Chronic hepatitis B patients

Eligibility Criteria

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

Study Population

Patients aged 18 years and older with HBsAg positivity for more than six months and HBV-DNA level \>2,000 IU/ml were included in the study. The exclusion criteria were established as presence of cirrhosis, alcohol consumption \>140 g/week for women and 210 g/week for men, hepatitis C, hepatitis D and/or HIV coinfections.

You may qualify if:

• Patients aged 18 years and older with HBsAg positivity for more than six months
• Patients have HBV-DNA level \>2,000 IU/ml for more than six months

You may not qualify if:

• Presence of cirrhosis
• Alcohol consumption \>140 g/week in women and 210 g/week in men
• Hepatitis C coinfection
• Hepatitis D and/or HIV coinfections

Sponsors & Collaborators

• Yaşar Bayındır, MD: lead
• Nobel Pharmaceuticals: collaborator

Study Sites (1)

Guven Hospital

Ankara, TR-06540, Turkey (Türkiye)

Location

Related Publications (4)

• Vittal A, Ghany MG. WHO Guidelines for Prevention, Care and Treatment of Individuals Infected with HBV: A US Perspective. Clin Liver Dis. 2019 Aug;23(3):417-432. doi: 10.1016/j.cld.2019.04.008.

  PMID: 31266617 RESULT

• 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 RESULT

• Wang L, Wang Y, Liu S, Zhai X, Zhou G, Lu F, Zhao J. Nonalcoholic fatty liver disease is associated with lower hepatitis B viral load and antiviral response in pediatric population. J Gastroenterol. 2019 Dec;54(12):1096-1105. doi: 10.1007/s00535-019-01594-6. Epub 2019 May 27.

  PMID: 31134334 RESULT

• Jiang K, Zhang L, Li J, Hu H, Huang Q, Qiu T, Mo X, Ren J, Guo W, Tao Y, Cui H, Zuo Y, Chen X, Xie Y, Li Y, Liang H, Liu Z, Xie L, Mao R, Jiang Q, Huang K. Diagnostic efficacy of FibroScan for liver inflammation in patients with chronic hepatitis B: a single-center study with 1185 liver biopsies as controls. BMC Gastroenterol. 2022 Jan 29;22(1):37. doi: 10.1186/s12876-022-02108-0.

  PMID: 35090390 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy materials

MeSH Terms

Conditions

Hepatitis B, Chronic; Fatty Liver; Metabolic Syndrome; Liver Cirrhosis

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mustafa Kemal Çelen, MD

  Dicle University, Medical Faculty, Department of Infectious Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Prof. Dr., M.D.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 27, 2024
• Study Start: January 2, 2023
• Primary Completion: April 25, 2023
• Study Completion: May 15, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)