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Completed

NCT Number: NCT01913431

Baracle Tab. ® Versus Baraclude Tab.® for Patients With 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.

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Key information

Conditions

HBeAg-Positive Chronic Hepatitis B

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baracle Tab.®

Drug

Baraclude Tab.®

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 1, 2013
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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