Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
NCT ID: NCT01026610
Last Updated: 2012-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
115 participants
INTERVENTIONAL
2009-08-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this study, the treatment period is 48-week with 24-week of follow-up period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LB80380 90 mg
LB80380 90 mg (90 mg + placebo), once daily oral dose
LB80380 90 mg
LB80380 90 mg + placebo tablets, once daily, for 48 weeks
LB80380 150 mg
LB80380 150 mg (60 mg + 90 mg), once daily oral dose
LB80380 150 mg
LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
entecavir 0.5 mg
entecavir 0.5 mg, once daily oral dose
entecavir 0.5 mg
entecavir 0.5 mg tablet, once daily, for 48 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LB80380 90 mg
LB80380 90 mg + placebo tablets, once daily, for 48 weeks
LB80380 150 mg
LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
entecavir 0.5 mg
entecavir 0.5 mg tablet, once daily, for 48 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic hepatitis B
* Not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before Screening
* Not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within Screening
* Compensated chronic hepatitis B
* HBeAg positive or HBeAg negative
* Elevated serum ALT level (1.2-10 X ULN, inclusive)
Exclusion Criteria
* Decompensated liver disease
* Creatinine clearance (calculated by Cockroft-Gault formula) less than 50 ml/min
* Screening alpha-fetoprotein (AFP) value greater than or equal to 50 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC
* Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
* Pregnancy or breast-feeding
* Patient is currently abusing alcohol or illicit drugs
* Significant systemic illnesses other than liver diseases
* Presence of other causes of liver disease
* A history of organ transplantation
Presence of anti-HBs at screening
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LG Life Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Mary Hospital
Hong Kong, , China
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, Inchen, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Pusan National University Yangsan Hospital
Pusan, , South Korea
Kangnam Severance Hospital, Yonsei University
Seoul, , South Korea
Korea University Medical Center
Seoul, , South Korea
Severance Hospital of Yonsei University
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fung J, Lai CL, Yuen MF. LB80380: a promising new drug for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2008 Oct;17(10):1581-8. doi: 10.1517/13543784.17.10.1581.
Yuen MF, Lee SH, Kang HM, Kim CR, Kim J, Ngai V, Lai CL. Pharmacokinetics of LB80331 and LB80317 following oral administration of LB80380, a new antiviral agent for chronic hepatitis B (CHB), in healthy adult subjects, CHB patients, and mice. Antimicrob Agents Chemother. 2009 May;53(5):1779-85. doi: 10.1128/AAC.01290-08. Epub 2009 Feb 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BVCL007
Identifier Type: -
Identifier Source: org_study_id