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

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LB80380 90 mg
LB80380 150 mg
entecavir 0.5 mg
Sponsored by
LG Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic hepatitis B, LB80380, treatment-naive, entecavir

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen Mary Hospital
  • Inha University Hospital
  • Hanyang University Guri Hospital
  • Kyungpook National University Hospital
  • Pusan National University Yangsan Hospital
  • Kangnam Severance Hospital, Yonsei University
  • Korea University Medical Center
  • Severance Hospital of Yonsei University
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

LB80380 90 mg

LB80380 150 mg

entecavir 0.5 mg

Arm Description

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

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

entecavir 0.5 mg, once daily oral dose

Outcomes

Primary Outcome Measures

Changes in HBV DNA level (log10) from baseline

Secondary Outcome Measures

Proportion of patients with undetectable serum HBV DNA
Proportion of patients with HBeAg seroconversion
Proportion of patients with ALT normalization
Safety assessment during the whole study period

Full Information

First Posted
December 3, 2009
Last Updated
October 4, 2012
Sponsor
LG Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01026610
Brief Title
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic hepatitis B, LB80380, treatment-naive, entecavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LB80380 90 mg
Arm Type
Experimental
Arm Description
LB80380 90 mg (90 mg + placebo), once daily oral dose
Arm Title
LB80380 150 mg
Arm Type
Experimental
Arm Description
LB80380 150 mg (60 mg + 90 mg), once daily oral dose
Arm Title
entecavir 0.5 mg
Arm Type
Active Comparator
Arm Description
entecavir 0.5 mg, once daily oral dose
Intervention Type
Drug
Intervention Name(s)
LB80380 90 mg
Other Intervention Name(s)
LB80380
Intervention Description
LB80380 90 mg + placebo tablets, once daily, for 48 weeks
Intervention Type
Drug
Intervention Name(s)
LB80380 150 mg
Other Intervention Name(s)
LB80380
Intervention Description
LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
Intervention Type
Drug
Intervention Name(s)
entecavir 0.5 mg
Other Intervention Name(s)
Baraclude
Intervention Description
entecavir 0.5 mg tablet, once daily, for 48 weeks
Primary Outcome Measure Information:
Title
Changes in HBV DNA level (log10) from baseline
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Proportion of patients with undetectable serum HBV DNA
Time Frame
At Week 24 or Week 48
Title
Proportion of patients with HBeAg seroconversion
Time Frame
At Week 24 or Week 48
Title
Proportion of patients with ALT normalization
Time Frame
At Week 24 or Week 48
Title
Safety assessment during the whole study period
Time Frame
At Week 24 or Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Inha University Hospital
City
Incheon
State/Province
Inchen
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri
State/Province
Kyunggi-do
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Kangnam Severance Hospital, Yonsei University
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital of Yonsei University
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
18808318
Citation
Fung J, Lai CL, Yuen MF. LB80380: a promising new drug for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2008 Oct;17(10):1581-8. doi: 10.1517/13543784.17.10.1581.
Results Reference
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PubMed Identifier
19223649
Citation
Yuen MF, Lee SH, Kang HM, Kim CR, Kim J, Ngai V, Lai CL. Pharmacokinetics of LB80331 and LB80317 following oral administration of LB80380, a new antiviral agent for chronic hepatitis B (CHB), in healthy adult subjects, CHB patients, and mice. Antimicrob Agents Chemother. 2009 May;53(5):1779-85. doi: 10.1128/AAC.01290-08. Epub 2009 Feb 17.
Results Reference
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Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

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