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

Dong-A ST Co., Ltd.1 site in 1 country118 target enrollmentSeptember 12, 2013

ConditionsHBeAg-Positive Chronic Hepatitis B

InterventionsBaracle Tab.®Baraclude Tab.®

DrugsBaracle Tab.®Baraclude Tab.®

Overview

Phase: Phase 4
Intervention: Baracle Tab.®
Conditions: HBeAg-Positive Chronic Hepatitis B
Sponsor: Dong-A ST Co., Ltd.
Enrollment: 118
Locations: 1
Primary Endpoint: the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 12, 2013

End Date

November 6, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dong-A ST Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Baracle Tab.®

(It can be also placebo) dosage: 2 tablets daily for 48 weeks

Intervention: Baracle Tab.®

Baraclude Tab.®

(It can be also placebo) dosage: 2 tablets daily for 48 weeks

Intervention: Baraclude Tab.®

Outcomes

Primary Outcomes

the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)

Time Frame: 52 weeks

measured at 24th week of the administration

Secondary Outcomes

the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)(52 weeks)
the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)(52 weeks)
the percentage of participants who have lost HBeAg(52 weeks)