Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
NCT ID: NCT01913431
Last Updated: 2017-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
118 participants
INTERVENTIONAL
2013-09-12
2015-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Baracle Tab.®
(It can be also placebo) dosage: 2 tablets daily for 48 weeks
Baracle Tab.®
Baraclude Tab.®
(It can be also placebo) dosage: 2 tablets daily for 48 weeks
Baraclude Tab.®
Interventions
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Baracle Tab.®
Baraclude Tab.®
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Han Chu Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Si Hyun Bae, M.D
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Ju Hyun Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gachon University of Medicine and Science Gil Medical Center
Jae Seok Hwang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Keimyung University Dongsan Medical Center
So Young Kwon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Hospital
Won Young Tak
Role: PRINCIPAL_INVESTIGATOR
Kyunpook National University Hospital
Jong Eun Yeon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Korae University Guro Hospital
Sang Young Han, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dong-A University Hospital
Joon Hyouk Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Jung Hwan Yoon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Sang Hoon Ahn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Neung Hwa Park, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ulsan University Hospital
Youn Jae Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Inje University
In Hee Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Byung Seok Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chungnam National University Hospital
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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ETV_HB_IV
Identifier Type: -
Identifier Source: org_study_id
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