Relationship Between MAFLD and Liver Fibrosis Progression in Patients With Chronic Hepatitis B: a Multicenter Retrospective Cohort Study

Hepatitis B, Chronic Clinical Trial

— MAFLD-HBV 1  

Official title:

Relationship Between Metabolic Dysfunction Associated Fatty Liver Disease and Liver Fibrosis Progression in Patients With Chronic Hepatitis B: a Multicenter Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708560
• Other study ID #: MEC-2021-0919
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2023
• Source: Erasmus Medical Center
• Contact: Lesley Patmore, MD
• Phone: 010 704 0704
• Email: l.patmore[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multicenter retrospective study aims to study the association between the presence of MAFLD and change in liver stiffness over time in untreated and treated patients with chronic hepatitis B

Description:

This project is a multicenter retrospective cohort study. All CHB patients who underwent at least 2 liver stiffness assessments with a Fibroscan device at least 6 months apart are eligible for enrolment. At baseline (defined as the first liver stiffness assessment) patients will be allocated to one of 4 groups (figure) based on use of antiviral therapy and presence of MAFLD. MAFLD is defined as presence of steatosis (based on ultrasound, histology or controlled attenuation parameter) in the presence of overweight (BMI >23 for Asians or >25 for Caucasians), diabetes mellitus, or at least 2 minor metabolic dysfunction criteria.(9) Baseline and follow-up data on biochemistry, virology, liver stiffness and clinical outcomes will be collected for all eligible patients. In case of initiation of antiviral therapy or development of MAFLD during follow-up, patients will transition to the appropriate cohort from that time-point onwards.

To ascertain the influence of the presence of MAFLD on liver stiffness progression, changes in liver stiffness will be compared within study groups (ie. cohort A vs B and cohort C vs D). To study the influence of antiviral therapy on liver stiffness progression in relation to presence of MAFLD, liver stiffness dynamics will be compared in cohort B vs cohort D (figure). The latter analysis will also be performed in the subgroup of patients with low levels of viremia (HBV DNA <2,000 IU/mL) and/or low levels of ALT (< 2 times the upper limit of normal).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic hepatitis B monoinfection

• At least two liver stiffness measurements more than 6 months apart

• Availability of data on hepatic steatosis (ultrasound, controlled attenuation parameter or histology) within 1 year of baseline

Exclusion Criteria:

• antiviral therapy with drugs other than entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide (for group 2 only)

• Presence of concomitant liver disease such as Wilson's disease, autoimmune hepatitis, hemochromatosis or alcohol abuse (>21 alcoholic drinks/week, female's >14/week)

• Presence of secondary causes of hepatic steatosis (medication, alcohol abuse)

• Coinfection with HCV, HIV, HEV

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Liver Cirrhosis

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Albert Schweitzer ziekenhuis	Dordrecht
Netherlands	Maastricht UMC+	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the association between presence of MAFLD and change in liver stiffness over time in untreated patients with chronic hepatitis B		12 months
Primary	Study the association between presence of MAFLD and change in liver stiffness over time in patients with chronic hepatitis B who initiate antiviral therapy		12 months
Primary	Assess the influence of antiviral therapy on liver stiffness changes over time in CHB patients with and without MAFLD		12 months