NCT01913431

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 Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 12, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2015

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

July 28, 2013

Last Update Submit

August 30, 2017

Conditions

HBeAg-Positive Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)

    measured at 24th week of the administration

    52 weeks

Secondary Outcomes (3)

  • the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)

    52 weeks

  • the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)

    52 weeks

  • the percentage of participants who have lost HBeAg

    52 weeks

Study Arms (2)

Baracle Tab.®

EXPERIMENTAL

(It can be also placebo) dosage: 2 tablets daily for 48 weeks

Drug: Baracle Tab.®

Baraclude Tab.®

EXPERIMENTAL

(It can be also placebo) dosage: 2 tablets daily for 48 weeks

Drug: Baraclude Tab.®

Interventions

Baracle Tab.®DRUG
Baracle Tab.®
Baraclude Tab.®DRUG
Baraclude Tab.®

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

entecavir

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2013

First Posted

August 1, 2013

Study Start

September 12, 2013

Primary Completion

November 6, 2015

Study Completion

November 6, 2015

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

KR(1)