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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01242787
Recruitment Status : Unknown
Verified April 2012 by LG Life Sciences.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2010
Last Update Posted : April 16, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: LB80380 Drug: Entecavir 0.5 mg Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
Active Comparator: Entecavir 0.5 mg
Entecavir 0.5 mg
Drug: Entecavir 0.5 mg
Entecavir 0.5 mg, by oral for 48 weeks

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

Primary Outcome Measures :
  1. Percentage of patients showing HBV DNA mutation [ Time Frame: at Week 48 ]
    Safety assessment including adverse events, laboratory abnormalities and DNA mutation

Secondary Outcome Measures :
  1. Change of HBV DNA from Baseline of LG-BVCL007 study [ Time Frame: at Week 48 ]
    Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01242787

Queen Mary Hospital
Hong Kong, China
Korea, Republic of
Severance Hospital of Yonsei University and other 8 sites in Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences

Publications of Results:
Responsible Party: LG Life Sciences Identifier: NCT01242787     History of Changes
Other Study ID Numbers: BVCL008
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: April 2012

Keywords provided by LG Life Sciences:
Chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents