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Completed

NCT Number: NCT01026610

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen Mary Hospital, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LB80380 90 mg

Drug

LB80380 90 mg + placebo tablets, once daily, for 48 weeks

Other names: LB80380

LB80380 150 mg

Drug

LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks

Other names: LB80380

entecavir 0.5 mg

Drug

entecavir 0.5 mg tablet, once daily, for 48 weeks

Other names: Baraclude

Primary outcomes

  1. Changes in HBV DNA level (log10) from baseline

    Time frame: At Week 24

Secondary outcomes

  1. Proportion of patients with undetectable serum HBV DNA

    Time frame: At Week 24 or Week 48

  2. Proportion of patients with HBeAg seroconversion

    Time frame: At Week 24 or Week 48

  3. Proportion of patients with ALT normalization

    Time frame: At Week 24 or Week 48

  4. Safety assessment during the whole study period

    Time frame: At Week 24 or Week 48

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Dec 4, 2009
Registry last updated
Oct 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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