Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Multinational, Multi-center, Open, Comparative, Paralleled, Roll-over Study to Assess the Safety and Antiviral Activity of LB80380 Tablet Compared to Entecavir 0.5 mg After Additional 48 Weeks of Treatment in Chronic Hepatitis B Patients Who Have Completed LG-BVCL007 Study

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: LB80380
* Drug: Entecavir 0.5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who are able to participate in this expanded study without any interruption after completing 48 weeks treatment of LG-BVCL007 study Exclusion Criteria: Co-infection with hepatitis C or D virus (HCV or HDV) or HIV Decompensated liver disease ALT > 10 x ULN Creatinine clearance (calculated by cockcroft-gault formula) less than 50 ml/min 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 Plan for liver transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Entecavir 0.5 mg<br>Entecavir 0.5 mg | Drug: Entecavir 0.5 mg<br>* Entecavir 0.5 mg, by oral for 48 weeks<br>|
| Experimental: LB80380<br>Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study) | Drug: LB80380<br>* Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients showing HBV DNA mutation | Safety assessment including adverse events, laboratory abnormalities and DNA mutation | at Week 48 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis B, LB80380, treatment-naive, entecavir, Extension