Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
A Phase IIb, Open, Multinational, Multi-center, Randomised, Comparative, Parallel Study to Assess the Safety and Antiviral Activity of LB80380 Compared to Entecavir 0.5 mg in Chronic Hepatitis B Patients for 48 Weeks With a Planned Analysis of Efficacy and Safety at Week 24 of the Treatment for Selecting Optimal Dose
1 other identifier
interventional
115
2 countries
10
Brief Summary
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2009
10 active sites
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
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 3, 2009
CompletedFirst Posted
Study publicly available on registry
December 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedOctober 5, 2012
October 1, 2012
1.3 years
December 3, 2009
October 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in HBV DNA level (log10) from baseline
At Week 24
Secondary Outcomes (4)
Proportion of patients with undetectable serum HBV DNA
At Week 24 or Week 48
Proportion of patients with HBeAg seroconversion
At Week 24 or Week 48
Proportion of patients with ALT normalization
At Week 24 or Week 48
Safety assessment during the whole study period
At Week 24 or Week 48
Study Arms (3)
LB80380 90 mg
EXPERIMENTALLB80380 90 mg (90 mg + placebo), once daily oral dose
LB80380 150 mg
EXPERIMENTALLB80380 150 mg (60 mg + 90 mg), once daily oral dose
entecavir 0.5 mg
ACTIVE COMPARATORentecavir 0.5 mg, once daily oral dose
Interventions
LB80380 90 mg + placebo tablets, once daily, for 48 weeks
LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
entecavir 0.5 mg tablet, once daily, for 48 weeks
Eligibility Criteria
You may qualify if:
- Female or male, 18 to 65 years of age, inclusive
- 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)
You may not qualify if:
- Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (10)
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
Related Publications (2)
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.
PMID: 18808318BACKGROUNDYuen 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.
PMID: 19223649BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2009
First Posted
December 4, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2010
Study Completion
May 1, 2011
Last Updated
October 5, 2012
Record last verified: 2012-10