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

Dong-A ST

Status and phase

Completed

Phase 4

Conditions

HBeAg-Positive Chronic Hepatitis B

Treatments

Drug: Baracle Tab.®

Drug: Baraclude Tab.®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01913431

ETV_HB_IV

Details and patient eligibility

About

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.

Enrollment

118 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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