Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorTaichung Veterans General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 20 years of age
Detectable serum HBsAg
Chronic HBV infection under ETV therapy
ETV users who are unsatisfied with the efficacy and/or feel inconvenient of ETV therapy
Disqualifiers
End stage renal disease (estimated glomerular filtration rate [eGRF]< 15 mL/min/1.73m2) without dialysis
Co-infected with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
Any active malignancies
Under immunosuppressants
Trial population
This prospective cohort study will enroll CHB patients who are unsatisfied to ETV therapy. The patient selection in this study is essentially based on a principle of shared decision making, and not only the physician decides whether to change the treatment. In the initial screening period, study subjects will be selected according to the inclusion and exclusion criteria, therefore only patients who complain the efficacy and/or inconvenience of ETV therapy (Inclusion criteria 4), will be invited to join this study. After discussing with the physician together, the study subjects must sign the inform consents before going into the next step (baseline condition evaluation).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
tenofovir alafenamide (TAF)
DrugTAF switch therapy in CHB patients who are unsatisfied to ETV therapy.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate/ concentration of renal function markers
The changes of eGFR, urine protein, urine beta 2-microglubulin, etc.
Time frame
week 482
HBV viral load
Time frame
week 483
The satisfaction (including drug adherence) to TAF switch therapy
The changes of TSQM-9 questionnaire, MMAS-8 questionnaire
Time frame
week 48Secondary outcomes
1
Rate/ concentration of renal function markers
The changes of eGFR, urine protein, urine beta 2-microglubulin, etc.
Time frame
week 1442
HBV viral load
Time frame
week 1443
The satisfaction (including drug adherence) to TAF switch therapy
The changes of TSQM-9 questionnaire, MMAS-8 questionnaire
Time frame
week 1444
Concentration of biochemical markers
bilirubin, AST, ALT
Time frame
week 144Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Taichung Veterans General Hospital
Lead sponsor
Institute of Adherence to Medication
Collaborator
Source ClinicalTrials.gov