NCT05583006Recruiting
Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
A Prospective Cohort Study of Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B Patients Who Are Unsatisfied to Entecavir Therapy
Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 14 Oct 2022
- Start date
- 6 Nov 2023
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Taichung Veterans General Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT05583006
What you commit to
- Study type: Observational
- Planned participants: 60
- From 6 Nov 2023 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Known allergy to tenofovir-contained regimens
Other
- Under immunosuppressants
Who the study is looking for
- 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
- No contraindications for TAF switch therapy
- HBV antiviral period expectancy for at least 1 year
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.