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

Phase 4

Completed

• Conditions: HBeAg-Positive Chronic Hepatitis B
• Interventions: Drug: Baracle Tab.®; Drug: Baraclude Tab.®

• Registration Number: NCT01913431
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-28
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Study Start: 2013-09-12
• Primary Completion: 2015-11-06
• Study Completion: 2015-11-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baracle Tab.®	Baracle Tab.®	(It can be also placebo) dosage: 2 tablets daily for 48 weeks
Baraclude Tab.®	Baraclude Tab.®	(It can be also placebo) dosage: 2 tablets daily for 48 weeks

Primary Outcome Measures

Name	Time	Method
the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)	52 weeks	measured at 24th week of the administration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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