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The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type hepatitis B virus (HBV). LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.
This study is an extension study of the Phase IIb (Protocol No. LG-BVCL007), the treatment period of this study is 48-week with 24-week of follow-up period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir 0.5 mg | Active Comparator | Entecavir 0.5 mg |
|
| LB80380 | Experimental | Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LB80380 | Drug | Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients showing HBV DNA mutation | Safety assessment including adverse events, laboratory abnormalities and DNA mutation | at Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of HBV DNA from Baseline of LG-BVCL007 study | Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion | at Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | China | ||||
| Severance Hospital of Yonsei University and other 8 sites in Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18808318 | Result | 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. | |
| 19223649 | Result | 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. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C487369 | ((1-((2-amino-9H-purin-9-yl)methyl)cyclopropyl)oxy)methylphosphonic acid dipivoxyl |
| C413685 | entecavir |
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| Entecavir 0.5 mg | Drug | Entecavir 0.5 mg, by oral for 48 weeks |
|
| Seoul |
| South Korea |
| 20091678 | Result | Yuen MF, Han KH, Um SH, Yoon SK, Kim HR, Kim J, Kim CR, Lai CL. Antiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease. Hepatology. 2010 Mar;51(3):767-76. doi: 10.1002/hep.23462. |
| 17302367 | Result | Yuen MF, Kim J, Kim CR, Ngai V, Yuen JC, Min C, Kang HM, Shin BS, Yoo SD, Lai CL. A randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B. Antivir Ther. 2006;11(8):977-83. |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |