UnknownNot Applicable

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

Netherlands800 participantsStarted 2022-03-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Study the association between presence of MAFLD and change in liver stiffness over time in untreated patients with chronic hepatitis B

Timeframe: 12 months

Study the association between presence of MAFLD and change in liver stiffness over time in patients with chronic hepatitis B who initiate antiviral therapy

Timeframe: 12 months

Assess the influence of antiviral therapy on liver stiffness changes over time in CHB patients with and without MAFLD

Timeframe: 12 months

Trial details

NCT IDNCT05708560

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-31

Contact for this trial

Lesley Patmore, MD

010 704 0704 l.patmore@erasmusmc.nl

View on ClinicalTrials.gov More Hepatitis B, Chronic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Study the association between presence of MAFLD and change in liver stiffness over time in untreated patients with chronic hepatitis B

Timeframe: 12 months

Study the association between presence of MAFLD and change in liver stiffness over time in patients with chronic hepatitis B who initiate antiviral therapy

Timeframe: 12 months

Assess the influence of antiviral therapy on liver stiffness changes over time in CHB patients with and without MAFLD

Timeframe: 12 months