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

Study Overview
=================
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.

Detailed Description
-----------------
LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection. In this study, the treatment period is 48-week with 24-week of follow-up period.

Official Title
-----------------
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

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: LB80380 90 mg
* Drug: LB80380 150 mg
* Drug: entecavir 0.5 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LB80380 90 mg<br>LB80380 90 mg (90 mg + placebo), once daily oral dose | Drug: LB80380 90 mg<br>* LB80380 90 mg + placebo tablets, once daily, for 48 weeks<br>* Other names: LB80380;|
| Experimental: LB80380 150 mg<br>LB80380 150 mg (60 mg + 90 mg), once daily oral dose | Drug: LB80380 150 mg<br>* LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks<br>* Other names: LB80380;|
| Active Comparator: entecavir 0.5 mg<br>entecavir 0.5 mg, once daily oral dose | Drug: entecavir 0.5 mg<br>* entecavir 0.5 mg tablet, once daily, for 48 weeks<br>* Other names: Baraclude;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HBV DNA level (log10) from baseline |  | At Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

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