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

LG Life Sciences

Status and phase

Unknown

Phase 2

Conditions

Chronic Hepatitis B

Treatments

Drug: Entecavir 0.5 mg

Drug: LB80380

Study type

Interventional

Funder types

Industry

Identifiers

NCT01242787

BVCL008

Details and patient eligibility

About

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.

Full 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

Enrollment

115 estimated patients

Sex

All

Ages

18 to 66 years old

Volunteers

No 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