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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01913431
First Posted: August 1, 2013
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
  Purpose
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.

Condition Intervention Phase
HBeAg-Positive Chronic Hepatitis B Drug: Baracle Tab.® Drug: Baraclude Tab.® Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10) [ Time Frame: 52 weeks ]
    measured at 24th week of the administration


Secondary Outcome Measures:
  • the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre) [ Time Frame: 52 weeks ]
    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 ]
    measured at 24th/48th week of the administration

  • the percentage of participants who have lost HBeAg [ Time Frame: 52 weeks ]
    HBeAg of the participants was found positive at their screening visit. Also, the measurement performs 24th/48th week of the administration.


Enrollment: 118
Actual Study Start Date: September 12, 2013
Study Completion Date: November 6, 2015
Primary Completion Date: November 6, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baracle Tab.®
(It can be also placebo) dosage: 2 tablets daily for 48 weeks
Drug: Baracle Tab.®
Experimental: Baraclude Tab.®
(It can be also placebo) dosage: 2 tablets daily for 48 weeks
Drug: Baraclude Tab.®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913431


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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. 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
  More Information

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01913431     History of Changes
Other Study ID Numbers: ETV_HB_IV
First Submitted: July 28, 2013
First Posted: August 1, 2013
Last Update Posted: August 31, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents