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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01026610
First received: December 3, 2009
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
 Drug: LB80380 90 mg
Drug: LB80380 150 mg
Drug: entecavir 0.5 mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Changes in HBV DNA level (log10) from baseline [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with undetectable serum HBV DNA [ Time Frame: At Week 24 or Week 48 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with HBeAg seroconversion [ Time Frame: At Week 24 or Week 48 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with ALT normalization [ Time Frame: At Week 24 or Week 48 ] [ Designated as safety issue: Yes ]
  • Safety assessment during the whole study period [ Time Frame: At Week 24 or Week 48 ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Baraclude

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026610

Locations
China
Queen Mary Hospital
Hong Kong, China
Korea, Republic of
Inha University Hospital
Incheon, Inchen, Korea, Republic of
Hanyang University Guri Hospital
Guri, Kyunggi-do, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Korea, Republic of
Korea University Medical Center
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Severance Hospital of Yonsei University
Seoul, Korea, Republic of
Kangnam Severance Hospital, Yonsei University
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

Publications:

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01026610     History of Changes
Other Study ID Numbers: BVCL007
Study First Received: December 3, 2009
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Hong Kong: Department of Health

Keywords provided by LG Life Sciences:
Chronic hepatitis B
LB80380
treatment-naive
entecavir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013