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

Phase 2

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Entecavir 0.5 mg; Drug: LB80380

• Registration Number: NCT01242787
• Lead Sponsor: LG Life Sciences

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

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-16
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir 0.5 mg	Entecavir 0.5 mg	Entecavir 0.5 mg
LB80380	LB80380	Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Queen Mary Hospital; 🇨🇳 Hong Kong, China

Severance Hospital of Yonsei University and other 8 sites in Korea; 🇰🇷 Seoul, Korea, Republic of