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

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: LB80380 Drug: Entecavir 0.5 mg	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Entecavir Recombinant Hepatitis B vaccine Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:

Percentage of patients showing HBV DNA mutation [ Time Frame: at Week 48 ] [ Designated as safety issue: Yes ]
Safety assessment including adverse events, laboratory abnormalities and DNA mutation

Secondary Outcome Measures:

Change of HBV DNA from Baseline of LG-BVCL007 study [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion

Estimated Enrollment:	115
Study Start Date:	August 2010
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Entecavir 0.5 mg Entecavir 0.5 mg	Drug: Entecavir 0.5 mg Entecavir 0.5 mg, by oral for 48 weeks
Experimental: LB80380 Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)	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)

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242787

Locations

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

Sponsors and Collaborators

LG Life Sciences

More Information

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.

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.

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.

Responsible Party:	LG Life Sciences
ClinicalTrials.gov Identifier:	NCT01242787 History of Changes
Other Study ID Numbers:	BVCL008
Study First Received:	November 12, 2010
Last Updated:	April 13, 2012
Health Authority:	United States: Food and Drug Administration Hong Kong: Department of Health South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by LG Life Sciences:

Chronic hepatitis B
LB80380
treatment-naive
entecavir
Extension

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections

Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013