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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01913431
First received: July 28, 2013
Last updated: July 30, 2013
Last verified: July 2013

July 28, 2013
July 30, 2013
July 2013
June 2014   (final data collection date for primary outcome measure)
the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
measured at 24th week of the administration
Same as current
Complete list of historical versions of study NCT01913431 on ClinicalTrials.gov Archive Site
  • the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    measured at 24th/48th week of the administration
  • the percentage of participants who have lost HBeAg [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    HBeAg of the participants was found positive at their screening visit. Also, the measurement performs 24th/48th week of the administration.
Same as current
Not Provided
Not Provided
 
Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
HBeAg-Positive Chronic Hepatitis B
  • Drug: Baracle Tab.®
  • Drug: Baraclude Tab.®
  • Experimental: Baracle Tab.®
    (It can be also placebo) dosage: 2 tablets daily for 48 weeks
    Intervention: Drug: Baracle Tab.®
  • Experimental: Baraclude Tab.®
    (It can be also placebo) dosage: 2 tablets daily for 48 weeks
    Intervention: Drug: Baraclude Tab.®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
116
Not Provided
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Han Chu Lee, M.D 82-2-3010-7166 irb@amc.seoul.kr
Korea, Republic of
 
NCT01913431
ETV_HB_IV
Yes
Dong-A ST Co., Ltd.
Dong-A ST Co., Ltd.
Not Provided
Principal Investigator: Han Chu Lee, M.D. Asan Medical Center
Principal Investigator: Si Hyun Bae, M.D The Catholic University of Korea
Principal Investigator: Ju Hyun Kim, M.D. Gachon University of Medicine and Science Gil Medical Center
Principal Investigator: Jae Seok Hwang, M.D. Keimyung University Dongsan Medical Center
Principal Investigator: So Young Kwon, M.D. Konkuk University Hospital
Principal Investigator: Won Young Tak Kyunpook National University Hospital
Principal Investigator: Jong Eun Yeon, M.D. Korae University Guro Hospital
Principal Investigator: Sang Young Han, M.D. Dong-A University Hospital
Principal Investigator: Joon Hyouk Lee, M.D. Samsung Medical Center
Principal Investigator: Jung Hwan Yoon, M.D. Seoul National University Hospital
Principal Investigator: Sang Hoon Ahn, M.D. Yonsei University Severance Hospital
Principal Investigator: Neung Hwa Park, M.D. Ulsan University Hospital
Principal Investigator: Youn Jae Lee, M.D. Inje University
Principal Investigator: In Hee Kim, M.D. Chonbuk National University Hospital
Principal Investigator: Byung Seok Lee, M.D. Chungnam National University Hospital
Dong-A ST Co., Ltd.
July 2013

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