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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Entecavir 0.5 mg

Group Type ACTIVE_COMPARATOR

Entecavir 0.5 mg

Intervention Type DRUG

Entecavir 0.5 mg, by oral for 48 weeks

LB80380

Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)

Group Type EXPERIMENTAL

LB80380

Intervention Type DRUG

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

Interventions

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LB80380

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

Intervention Type DRUG

Entecavir 0.5 mg

Entecavir 0.5 mg, by oral for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No