Trial record 109 of 440 for:    hepatitis b | Open Studies

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ 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.


Estimated Enrollment: 116
Study Start Date: July 2013
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913431

Contacts
Contact: Han Chu Lee, M.D 82-2-3010-7166 irb@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Han Chu Lee, M.D    82-2-3010-7166    irb@amc.seoul.kr   
Principal Investigator: Han Chu Lee, M.D         
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. 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
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01913431     History of Changes
Other Study ID Numbers: ETV_HB_IV
Study First Received: July 28, 2013
Last Updated: July 30, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014