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

HBeAg-Positive Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913431
• Other study ID #: ETV_HB_IV
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2013
• Last updated: August 30, 2017
• Start date: September 12, 2013
• Est. completion date: November 6, 2015

Study information

• Verified date: August 2017
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 6, 2015
• Est. primary completion date: November 6, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HBeAg-Positive Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Baracle Tab.®

• Baraclude Tab.®

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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