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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01026610

Enrollment

115

Registered

2009-12-04

Start date

2009-08-31

Completion date

2011-05-31

Last updated

2012-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B, LB80380, treatment-naive, entecavir

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.

Interventions

DRUGLB80380 90 mg

LB80380 90 mg + placebo tablets, once daily, for 48 weeks

DRUGLB80380 150 mg

LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks

DRUGentecavir 0.5 mg

entecavir 0.5 mg tablet, once daily, for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in HBV DNA level (log10) from baseline	At Week 24

Secondary

Measure	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

Countries

China, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026