RecruitingPhase 4NCT03933384

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: an Open Label, Randomized Controlled Trial


Sponsor

Taichung Veterans General Hospital

Enrollment

140 participants

Start Date

Aug 19, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.


Eligibility

Min Age: 20 Years

Inclusion Criteria3

  • Patients more than 20 years old
  • Chronic hepatitis B patients
  • Patients who were indicated for hepatitis B virus antiviral therapy

Exclusion Criteria8

  • Decompensated liver disease (Child-Pugh B \&C)
  • End stage renal disease (eGRF < 15 ml/min/1.73m2)
  • Prior use of nucleot(s)ide analogues for chronic hepatitis B
  • Prior use of interferon for chronic hepatitis B within six months
  • Known history of human immunodeficiency virus or hepatitis C virus co-infection
  • Concurrent other uncontrolled malignancy
  • Women in pregnancy or lactation
  • Cannot conform to the study protocol of this study

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Interventions

DRUGTenofovir alafenamide

Tenofovir alafenamide 25mg/tab once daily

DRUGEntecavir

Entecavir 0.5mg/tab once daily


Locations(1)

Taichung Veterans General Hospital

Taichung, Taichung, Taiwan

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NCT03933384


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