drugset / Trial / NCT03485534

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

NCT03485534

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2018-01-23
Primary completion
2019-11-04
Completion
2019-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenofovir disoproxil fumarate Small molecule 245 mg
Subject Tenofovir disoproxil fumarate Small molecule 300 mg