Actively Recruiting
Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
Led by Taichung Veterans General Hospital · Updated on 2025-01-09
60
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
Sponsors
T
Taichung Veterans General Hospital
Lead Sponsor
I
Institute of Adherence to Medication
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 20 years of age
- Detectable serum hepatitis B surface antigen (HBsAg)
- Chronic hepatitis B infection currently treated with entecavir (ETV)
- Unsatisfied with the efficacy or convenience of ETV therapy
- No contraindications for switching to tenofovir alafenamide (TAF) therapy
- Expect to continue HBV antiviral treatment for at least 1 year
You will not qualify if you...
- End stage renal disease with estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73m2 and not on dialysis
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D virus
- Presence of any active cancers
- Currently using immunosuppressant medications
- Known allergy to tenofovir-containing medications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan, 40705
Actively Recruiting
Research Team
T
Teng-Yu Lee, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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