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Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B

NCT01913431 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2017-08-31

No results posted yet for this study

Summary

This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.

Conditions

  • HBeAg-Positive Chronic Hepatitis B

Interventions

DRUG

Baracle Tab.®

DRUG

Baraclude Tab.®

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Han Chu Lee, M.D. · Asan Medical Center

  • Si Hyun Bae, M.D · The Catholic University of Korea

  • Ju Hyun Kim, M.D. · Gachon University of Medicine and Science Gil Medical Center

  • Jae Seok Hwang, M.D. · Keimyung University Dongsan Medical Center

  • So Young Kwon, M.D. · Konkuk University Hospital

  • Won Young Tak · Kyunpook National University Hospital

  • Jong Eun Yeon, M.D. · Korae University Guro Hospital

  • Sang Young Han, M.D. · Dong-A University Hospital

  • Joon Hyouk Lee, M.D. · Samsung Medical Center

  • Jung Hwan Yoon, M.D. · Seoul National University Hospital

  • Sang Hoon Ahn, M.D. · Severance Hospital

  • Neung Hwa Park, M.D. · Ulsan University Hospital

  • Youn Jae Lee, M.D. · Inje University

  • In Hee Kim, M.D. · Chonbuk National University Hospital

  • Byung Seok Lee, M.D. · Chungnam National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-12
Primary Completion
2015-11-06
Completion
2015-11-06

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 NCT01913431 on ClinicalTrials.gov