Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
Launched by DONG-A ST CO., LTD. · Jul 30, 2013
Trial Information
Current as of April 27, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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
About Dong A St Co., Ltd.
Dong-A ST Co., Ltd. is a leading pharmaceutical and biotechnology company based in South Korea, dedicated to the research, development, and commercialization of innovative therapeutic solutions. With a robust portfolio spanning various therapeutic areas, including neurology, oncology, and cardiovascular health, Dong-A ST is committed to advancing healthcare through cutting-edge clinical research and high-quality products. The company emphasizes a patient-centered approach, collaborating with global partners to enhance treatment options and improve health outcomes worldwide. Through its rigorous clinical trials and commitment to scientific excellence, Dong-A ST strives to contribute meaningfully to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Patients applied
Trial Officials
Han Chu Lee, M.D.
Principal Investigator
Asan Medical Center
Si Hyun Bae, M.D
Principal Investigator
The Catholic University of Korea
Ju Hyun Kim, M.D.
Principal Investigator
Gachon University of Medicine and Science Gil Medical Center
Jae Seok Hwang, M.D.
Principal Investigator
Keimyung University Dongsan Medical Center
So Young Kwon, M.D.
Principal Investigator
Konkuk University Hospital
Won Young Tak
Principal Investigator
Kyunpook National University Hospital
Jong Eun Yeon, M.D.
Principal Investigator
Korae University Guro Hospital
Sang Young Han, M.D.
Principal Investigator
Dong-A University Hospital
Joon Hyouk Lee, M.D.
Principal Investigator
Samsung Medical Center
Jung Hwan Yoon, M.D.
Principal Investigator
Seoul National University Hospital
Sang Hoon Ahn, M.D.
Principal Investigator
Severance Hospital
Neung Hwa Park, M.D.
Principal Investigator
Ulsan University Hospital
Youn Jae Lee, M.D.
Principal Investigator
Inje University
In Hee Kim, M.D.
Principal Investigator
Chonbuk National University Hospital
Byung Seok Lee, M.D.
Principal Investigator
Chungnam National University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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