Clinical trial NCT01913431: Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HBeAg-Positive Chronic Hepatitis B
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-01
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)
timeFrame: 52 weeks
Secondary outcomes:
measure: the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)
timeFrame: 52 weeks
measure: the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)
timeFrame: 52 weeks
measure: the percentage of participants who have lost HBeAg
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Han Chu Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Si Hyun Bae, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University of Medicine and Science Gil Medical Center
name: Ju Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: Jae Seok Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkuk University Hospital
name: So Young Kwon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunpook National University Hospital
name: Won Young Tak
role: PRINCIPAL_INVESTIGATOR
affiliation: Korae University Guro Hospital
name: Jong Eun Yeon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University Hospital
name: Sang Young Han, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Joon Hyouk Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Jung Hwan Yoon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Sang Hoon Ahn, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulsan University Hospital
name: Neung Hwa Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Youn Jae Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: In Hee Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: Byung Seok Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: