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

Primary Purpose

HBeAg-Positive Chronic Hepatitis B

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Baracle Tab.®

Baraclude Tab.®

About this trial

This is an interventional treatment trial for HBeAg-Positive Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Baracle Tab.®

Baraclude Tab.®

Arm Description

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

Outcomes

Primary Outcome Measures

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

measured at 24th week of the administration

Secondary Outcome Measures

the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)

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)

measured at 24th/48th week of the administration

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.

Full Information

NCT ID

NCT01913431

First Posted

July 28, 2013

Last Updated

August 30, 2017

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01913431

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

September 12, 2013 (Actual)

Primary Completion Date

November 6, 2015 (Actual)

Study Completion Date

November 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HBeAg-Positive Chronic Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Baracle Tab.®

Arm Type

Experimental

Arm Description

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

Arm Title

Baraclude Tab.®

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Baracle Tab.®

Intervention Type

Drug

Intervention Name(s)

Baraclude Tab.®

Primary Outcome Measure Information:

Title

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

Description

measured at 24th week of the administration

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)

Description

measured at 24th/48th week of the administration

Time Frame

52 weeks

Title

the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)

Description

measured at 24th/48th week of the administration

Time Frame

52 weeks

Title

the percentage of participants who have lost HBeAg

Description

HBeAg of the participants was found positive at their screening visit. Also, the measurement performs 24th/48th week of the administration.

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials: