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

A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Group Study to Demonstrate the Comparison and Evaluation of Baracle Tab.® and Baraclude Tab.® for HBeAG Chronic Hepatitis B

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.

Study Overview

• Status: Completed
• Conditions: HBeAg-Positive Chronic Hepatitis B
• Intervention / Treatment: Drug: Baracle Tab.®; Drug: Baraclude Tab.®

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with HbeAg Chronic Hepatitis B for at least six months starting from the Screening visit
• Subjects with HBsAg-Positive diagnosed at the screening visit
• Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit
• For those who were diagnosed HBeAg-Positive, HBV DNA level should be equal or more than 1x10^5 copies/ml
• For those who were diagnosed HBeAg-Negative, HBV DNA level should be equal or more than 1x10^5 copies/ml
• Subjects who were NOT administrated any anti-viral agents including interferon or pegylated interferon

Exclusion Criteria:

• Subjects with HCV, HDV or HIV
• Subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin
• With medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein
• Less than 50ml/min of creatinine clearance diagnosed at the screening visit
• More than 50 ng/ml of alpha-fetoprotein at the screening visit
• Involved in other studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baracle Tab.®; (It can be also placebo) dosage: 2 tablets daily for 48 weeks	Drug: Baracle Tab.®
Experimental: Baraclude Tab.®; (It can be also placebo) dosage: 2 tablets daily for 48 weeks	Drug: Baraclude Tab.®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)	measured at 24th week of the administration	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)	measured at 24th/48th week of the administration	52 weeks
the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)	measured at 24th/48th week of the administration	52 weeks
the percentage of participants who have lost HBeAg	HBeAg of the participants was found positive at their screening visit. Also, the measurement performs 24th/48th week of the administration.	52 weeks

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Han Chu Lee, M.D., Asan Medical Center; Principal Investigator: Si Hyun Bae, M.D, The Catholic University of Korea; Principal Investigator: Ju Hyun Kim, M.D., Gachon University of Medicine and Science Gil Medical Center; Principal Investigator: Jae Seok Hwang, M.D., Keimyung University Dongsan Medical Center; Principal Investigator: So Young Kwon, M.D., Konkuk University Hospital; Principal Investigator: Won Young Tak, Kyunpook National University Hospital; Principal Investigator: Jong Eun Yeon, M.D., Korae University Guro Hospital; Principal Investigator: Sang Young Han, M.D., Dong-A University Hospital; Principal Investigator: Joon Hyouk Lee, M.D., Samsung Medical Center; Principal Investigator: Jung Hwan Yoon, M.D., Seoul National University Hospital; Principal Investigator: Sang Hoon Ahn, M.D., Severance Hospital; Principal Investigator: Neung Hwa Park, M.D., Ulsan University Hospital; Principal Investigator: Youn Jae Lee, M.D., Inje University; Principal Investigator: In Hee Kim, M.D., Chonbuk National University Hospital; Principal Investigator: Byung Seok Lee, M.D., Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2013
• Primary Completion (Actual): November 6, 2015
• Study Completion (Actual): November 6, 2015

Study Registration Dates

• First Submitted: July 28, 2013
• First Submitted That Met QC Criteria: July 30, 2013
• First Posted (Estimate): August 1, 2013

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Anti-Infective Agents; Antiviral Agents; Entecavir
• Other Study ID Numbers: ETV_HB_IV