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

Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03485534

Acronym

HBV

Enrollment

189

Registered

2018-04-02

Start date

2018-01-23

Completion date

2019-11-04

Last updated

2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Brief 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

Detailed 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 .

Interventions

DRUGTenofovir Disoproxil Fumarate

Viread 300mg

DRUGTenofovir Disoproxil

Virehepa 245mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open-label, randomized, Parallel

Eligibility

Sex/Gender

ALL

Age

19 Years to 69 Years

Healthy volunteers

Inclusion criteria

* Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months. * HBeAg negative and HBeAb positive at screening

Exclusion criteria

* Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study * Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study. * Decompensated liver disease defined as conjugated bilirubin \> 1.5 x ULN, prothrombin time (PT) \> 1.5 x ULN, platelets \< 75,000/mL, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage) * Significant renal, cardiovascular, pulmonary, or neurological disease * currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion

Design outcomes

Primary

Measure	Time frame	Description
HBV DNA inhibition	48weeks	plasma HBV DNA level of less than 400 copies per milliliter

Secondary

Measure	Time frame	Description
viral suppression	24weeks	an HBV DNA level of \<400 copies per milliliter

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026