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Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B

NCT05583006 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-01-09

No results posted yet for this study

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.

Conditions

  • Patient Satisfaction
  • Drug Adherence
  • Efficacy, Self
  • Safety Issues

Interventions

DRUG

tenofovir alafenamide (TAF)

TAF switch therapy in CHB patients who are unsatisfied to ETV therapy.

Sponsors & Collaborators

  • Institute of Adherence to Medication

    collaborator UNKNOWN

  • Taichung Veterans General Hospital

    lead OTHER

Principal Investigators

  • Teng-Yu Lee, MD, PhD · Taichung Veterans General Hospital

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2026-12-30
Completion
2028-12-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05583006 on ClinicalTrials.gov