Clinical trial NCT01026610: Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B
LB80380
treatment-naive
entecavir
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Changes in HBV DNA level (log10) from baseline
timeFrame: At Week 24
Secondary outcomes:
measure: Proportion of patients with undetectable serum HBV DNA
timeFrame: At Week 24 or Week 48
measure: Proportion of patients with HBeAg seroconversion
timeFrame: At Week 24 or Week 48
measure: Proportion of patients with ALT normalization
timeFrame: At Week 24 or Week 48
measure: Safety assessment during the whole study period
timeFrame: At Week 24 or Week 48
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Inchen
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Kyunggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital of Yonsei University
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
citation: 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.
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.