Status:
COMPLETED
Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
HBeAg-Positive Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 Ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2015
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01913431
Start Date
September 12 2013
End Date
November 6 2015
Last Update
August 31 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736