Clinical Trial

Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B

Recruiting
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Summary
Chronic hepatitis B (CHB) patients may be unsatisfied to entecavir (ETV) therapy due to the inconvenience in drug taking, i.e., fasting for more than 2 hours and/or dose adjustment according to estimated glomerular filtration rate (eGFR). However, tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with CHB, and is convenient in drug taking, i.e., once daily regardless food taking and renal function.Therefore,TAF can be a good option in CHB patients who are unsatisfied to ETV therapy. The aim of this prospective cohort study is to assess the improvement on satisfaction (including drug adherence) of TAF switch therapy in CHB patients who are unsatisfied to ETV therapy. In addition, with expected adherence improvement in TAF switch therapy, the efficacy of TAF switch therapy may be improved, and the efficacy benefits can be evaluated by the changes of some novel biomarkers, such as HBV core-related antigen (HBcrAg). The investigators therefore aim to conduct a prospective cohort study of TAF switch therapy for CHB patients who are unsatisfied to ETV therapy.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-10-14; most recent amendment 2025-01-07.
Status change: Not Yet Recruiting → Recruiting 2023-11-06
Trial Details
NCT Number NCT05583006
Lead Sponsor Taichung Veterans General Hospital
Collaborators: Institute of Adherence to Medication
Conditions Patient Satisfaction, Drug Adherence, Efficacy, Self, Safety Issues
Enrollment 60 participants
Start Date 2023-11-06
Primary Completion 2026-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-01-09