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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026610
• Other study ID #: BVCL007
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2009
• Last updated: October 4, 2012
• Start date: August 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2012
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Korea: Korea Food and Drug Administration (KFDA)Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• LB80380 90 mg
LB80380 90 mg + placebo tablets, once daily, for 48 weeks
• LB80380 150 mg
LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
• entecavir 0.5 mg
entecavir 0.5 mg tablet, once daily, for 48 weeks

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Hanyang University Guri Hospital	Guri	Kyunggi-do
Korea, Republic of	Inha University Hospital	Incheon	Inchen
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Kangnam Severance Hospital, Yonsei University	Seoul
Korea, Republic of	Korea University Medical Center	Seoul
Korea, Republic of	Severance Hospital of Yonsei University	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Countries where clinical trial is conducted

China,  Korea, Republic of, 

References & Publications (2)

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 . Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HBV DNA level (log10) from baseline		At Week 24	No
Secondary	Proportion of patients with undetectable serum HBV DNA		At Week 24 or Week 48	Yes
Secondary	Proportion of patients with HBeAg seroconversion		At Week 24 or Week 48	Yes
Secondary	Proportion of patients with ALT normalization		At Week 24 or Week 48	Yes
Secondary	Safety assessment during the whole study period		At Week 24 or Week 48	Yes