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

Phase 4

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Tenofovir Disoproxil; Drug: Tenofovir Disoproxil Fumarate

• Registration Number: NCT03485534
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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 .

Study Timeline

• Study Start: 2018-01-23
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-02
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir Disoproxil	Tenofovir Disoproxil	Tenofovir Disoproxil 245mg, a daily dose for 48 weeks
Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks

Primary Outcome Measures

Name	Time	Method
HBV DNA inhibition	48weeks	plasma HBV DNA level of less than 400 copies per milliliter

Secondary Outcome Measures

Name	Time	Method
viral suppression	24weeks	an HBV DNA level of \<400 copies per milliliter

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of