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

Chronic Hepatitis B Clinical Trial

— LB80380  

Official title:

A Multinational, Multi-center, Open, Comparative, Paralleled, Roll-over Study to Assess the Safety and Antiviral Activity of LB80380 Tablet Compared to Entecavir 0.5 mg After Additional 48 Weeks of Treatment in Chronic Hepatitis B Patients Who Have Completed LG-BVCL007 Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01242787
• Other study ID #: BVCL008
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 12, 2010
• Last updated: April 13, 2012
• Start date: August 2010
• Est. completion date: September 2012

Study information

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

Clinical Trial Summary

The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 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 hepatitis B virus (HBV). LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.

This study is an extension study of the Phase IIb (Protocol No. LG-BVCL007), the treatment period of this study is 48-week with 24-week of follow-up period

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

Inclusion Criteria:

• The patients who are able to participate in this expanded study without any interruption after completing 48 weeks treatment of LG-BVCL007 study

Exclusion Criteria:

• Co-infection with hepatitis C or D virus (HCV or HDV) or HIV

• Decompensated liver disease

• ALT > 10 x ULN

• Creatinine clearance (calculated by cockcroft-gault formula) less than 50 ml/min

• 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

• Plan for liver transplantation

Study Design

Allocation: Randomized, Endpoint Classification: Safety 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
Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)
• Entecavir 0.5 mg
Entecavir 0.5 mg, by oral for 48 weeks

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong
Korea, Republic of	Severance Hospital of Yonsei University and other 8 sites in Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Countries where clinical trial is conducted

China,  Korea, Republic of, 

References & Publications (4)

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, Han KH, Um SH, Yoon SK, Kim HR, Kim J, Kim CR, Lai CL. Antiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease. Hepatology. 2010 Mar;51(3):767-76. doi: 10.1002/hep. — View Citation

Yuen MF, Kim J, Kim CR, Ngai V, Yuen JC, Min C, Kang HM, Shin BS, Yoo SD, Lai CL. A randomized placebo-controlled, dose-finding study of oral LB80380 in HBeAg-positive patients with chronic hepatitis B. Antivir Ther. 2006;11(8):977-83. — 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 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients showing HBV DNA mutation	Safety assessment including adverse events, laboratory abnormalities and DNA mutation	at Week 48	Yes
Secondary	Change of HBV DNA from Baseline of LG-BVCL007 study	Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion	at Week 48	No