Last updated: January 23, 2023
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hepatitis
Liver Disorders
Hepatitis B
Treatment
N/AClinical Study ID
NCT05708560
MEC-2021-0919
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 attenuationparameter or histology) within 1 year of baseline
Exclusion
Exclusion Criteria:
- antiviral therapy with drugs other than entecavir, tenofovir disoproxil fumarate ortenofovir 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
Study Design
Total Participants: 800
Study Start date:
March 01, 2022
Estimated Completion Date:
January 31, 2023
Study Description
Connect with a study center
Amsterdam UMC
Amsterdam,
NetherlandsActive - Recruiting
Albert Schweitzer ziekenhuis
Dordrecht,
NetherlandsCompleted
Maastricht UMC+
Maastricht,
NetherlandsCompleted

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