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

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LB80380
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, Extension

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary Hospital
  • Severance Hospital of Yonsei University and other 8 sites in Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Entecavir 0.5 mg

LB80380

Arm Description

Entecavir 0.5 mg

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

Outcomes

Primary Outcome Measures

Percentage of patients showing HBV DNA mutation
Safety assessment including adverse events, laboratory abnormalities and DNA mutation

Secondary Outcome Measures

Change of HBV DNA from Baseline of LG-BVCL007 study
Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion

Full Information

First Posted
November 12, 2010
Last Updated
April 13, 2012
Sponsor
LG Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01242787
Brief Title
Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
Acronym
LB80380
Official Title
A Multinational, Multi-center, Open, Comparative, Paralleled, Roll-over Study to Assess the Safety and Antiviral Activity of LB80380 Tablet Compared to Entecavir 0.5 mg After Additional 48 Weeks of Treatment in Chronic Hepatitis B Patients Who Have Completed LG-BVCL007 Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

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 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

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, Extension

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Entecavir 0.5 mg
Arm Type
Active Comparator
Arm Description
Entecavir 0.5 mg
Arm Title
LB80380
Arm Type
Experimental
Arm Description
Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)
Intervention Type
Drug
Intervention Name(s)
LB80380
Intervention Description
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
Intervention Name(s)
Entecavir 0.5 mg
Intervention Description
Entecavir 0.5 mg, by oral for 48 weeks
Primary Outcome Measure Information:
Title
Percentage of patients showing HBV DNA mutation
Description
Safety assessment including adverse events, laboratory abnormalities and DNA mutation
Time Frame
at Week 48
Secondary Outcome Measure Information:
Title
Change of HBV DNA from Baseline of LG-BVCL007 study
Description
Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion
Time Frame
at Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Severance Hospital of Yonsei University and other 8 sites in Korea
City
Seoul
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
result
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
result
PubMed Identifier
20091678
Citation
Yuen MF, Han KH, Um SH, Yoon SK, Kim HR, Kim J, Kim CR, Lai CL. Antiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease. Hepatology. 2010 Mar;51(3):767-76. doi: 10.1002/hep.23462.
Results Reference
result
PubMed Identifier
17302367
Citation
Yuen MF, Kim J, Kim CR, Ngai V, Yuen JC, Min C, Kang HM, Shin BS, Yoo SD, Lai CL. A randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B. Antivir Ther. 2006;11(8):977-83.
Results Reference
result

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

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