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

LG Life Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: entecavir 0.5 mg; Drug: LB80380 90 mg; Drug: LB80380 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01026610

BVCL007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 3 patient groups

LB80380 90 mg

Experimental group

Description:

LB80380 90 mg (90 mg + placebo), once daily oral dose

Treatment:

Drug: LB80380 90 mg

LB80380 150 mg

Experimental group

Description:

LB80380 150 mg (60 mg + 90 mg), once daily oral dose

Treatment:

Drug: LB80380 150 mg

entecavir 0.5 mg

Active Comparator group

Description:

entecavir 0.5 mg, once daily oral dose

Treatment:

Drug: entecavir 0.5 mg