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

Condition(s) targeted: Chronic Hepatitis B

Intervention: LB80380 90 mg (Drug); LB80380 150 mg (Drug); entecavir 0.5 mg (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: LG Life Sciences

Overall contact:
Jiyoon Lee, Email: jiyoon@lgls.com

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.

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

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

Primary outcome: Changes in HBV DNA level (log10) from baseline

Secondary outcome:

Proportion of patients with undetectable serum HBV DNA

Proportion of patients with HBeAg seroconversion

Proportion of patients with ALT normalization

Safety assessment during the whole study period

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Jiyoon Lee, Email: jiyoon@lgls.com

Kyungpook Natioanl University Hospital, Daegu, Korea, Republic of; Recruiting
Young-Oh Kwon, Prof., Principal Investigator

Pusan National University Yangsan Hospital, Pusan, Korea, Republic of; Recruiting
Mong Cho, Prof., Principal Investigator

Kangnam Severance Hospital, Yonsei University, Seoul, Korea, Republic of; Recruiting
Kwan-Sik Lee, Prof., Principal Investigator

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea, Republic of; Recruiting
Seung-Kew Yoon, Prof., Principal Investigator

Korea University Medical Center, Seoul, Korea, Republic of; Recruiting
Soon-Ho Um, Prof., Principal Investigator

Severance Hospital of Yonsei University, Seoul, Korea, Republic of; Recruiting
Kwang-Hyub Han, Prof., Principal Investigator

Ulsan University Hospital, Ulsan, Korea, Republic of; Recruiting
Neung-Hwa Park, Prof., Principal Investigator

Queen Mary Hospital, Hong Kong, Hong Kong, China; Recruiting
Ching-Lung Lai, Prof., Principal Investigator

Inha University Hospital, Incheon, Inchen, Korea, Republic of; Recruiting
Jin Woo Lee, Prof., Principal Investigator

Hanyang University Guri Hospital, Guri, Kyunggi-do, Korea, Republic of; Recruiting
Joo Hyun Sohn, Prof., Principal Investigator

Related publications:

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. Review.

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. Epub 2009 Feb 17.

Starting date: August 2009
Last updated: March 16, 2010