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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01242787

Acronym

LB80380

Enrollment

115

Registered

2010-11-17

Start date

2010-08-31

Completion date

2012-09-30

Last updated

2012-04-16

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, Extension

Brief summary

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

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

Interventions

DRUGLB80380

Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)

DRUGEntecavir 0.5 mg

Entecavir 0.5 mg, by oral for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 66 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change of HBV DNA from Baseline of LG-BVCL007 study	at Week 48	Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion

Countries

China, South Korea

Outcome results

None listed

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