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
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 .
| Condition | chronic hepatitis b |
|---|---|
| Treatment | Tenofovir disoproxil, Tenofovir disoproxil fumarate |
| Clinical Study Identifier | NCT03485534 |
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Last Modified on | 22 January 2021 |
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