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

October 4, 2012 updated by: LG Life Sciences

A Phase IIb, Open, Multinational, Multi-center, Randomised, Comparative, Parallel Study to Assess the Safety and Antiviral Activity of LB80380 Compared to Entecavir 0.5 mg in Chronic Hepatitis B Patients for 48 Weeks With a Planned Analysis of Efficacy and Safety at Week 24 of the Treatment for Selecting Optimal Dose

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Queen Mary Hospital
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Yangsan Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Korea University Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital of Yonsei University
      • Seoul, Korea, Republic of
        • Kangnam Severance Hospital, Yonsei University
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital
    • Inchen
      • Incheon, Inchen, Korea, Republic of
        • Inha University Hospital
    • Kyunggi-do
      • Guri, Kyunggi-do, Korea, Republic of
        • Hanyang University Guri Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LB80380 90 mg
LB80380 90 mg (90 mg + placebo), once daily oral dose
Drug: LB80380 90 mg
LB80380 90 mg + placebo tablets, once daily, for 48 weeks
Other Names:
  • LB80380
Experimental: LB80380 150 mg
LB80380 150 mg (60 mg + 90 mg), once daily oral dose
Drug: LB80380 150 mg
LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
Other Names:
  • LB80380
Active Comparator: entecavir 0.5 mg
entecavir 0.5 mg, once daily oral dose
Drug: entecavir 0.5 mg
entecavir 0.5 mg tablet, once daily, for 48 weeks
Other Names:
  • Baraclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in HBV DNA level (log10) from baseline
Time Frame: At Week 24
At Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with undetectable serum HBV DNA
Time Frame: At Week 24 or Week 48
At Week 24 or Week 48
Proportion of patients with HBeAg seroconversion
Time Frame: At Week 24 or Week 48
At Week 24 or Week 48
Proportion of patients with ALT normalization
Time Frame: At Week 24 or Week 48
At Week 24 or Week 48
Safety assessment during the whole study period
Time Frame: At Week 24 or Week 48
At Week 24 or Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

December 3, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2012

Last Update Submitted That Met QC Criteria

October 4, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVCL007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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