Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients

  • STATUS
    Not Recruiting
  • participants needed
    189
  • sponsor
    Daewoong Pharmaceutical Co. LTD.
Updated on 22 January 2021
tenofovir
fumarate
hepatitis b antigen
chronic hepatitis
hepatitis b e antigen

Summary

This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate.

In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks

Description

Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase.

The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .

Details
Condition chronic hepatitis b
Treatment Tenofovir disoproxil, Tenofovir disoproxil fumarate
Clinical Study IdentifierNCT03485534
SponsorDaewoong Pharmaceutical Co. LTD.
Last Modified on22 January 2021

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