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

NCT03485534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2022-06-09

No results posted yet for this study

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

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Tenofovir Disoproxil Fumarate

Viread 300mg

DRUG

Tenofovir Disoproxil

Virehepa 245mg

Sponsors & Collaborators

  • C&R Research, Inc.

    collaborator INDUSTRY

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Principal Investigators

  • Youngsuk Lim, PHD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03485534 on ClinicalTrials.gov