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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

LG Life Sciences

ClinicalTrials.gov Identifier:

NCT01242787

First received: November 12, 2010

Last updated: April 13, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 12, 2010
Last Updated Date	April 13, 2012
Start Date ^ICMJE	August 2010
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 16, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01242787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 16, 2010)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
Official Title ^ICMJE	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
Brief 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.
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Hepatitis B
Intervention ^ICMJE	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) Drug: Entecavir 0.5 mg Entecavir 0.5 mg, by oral for 48 weeks
Study Arm (s)	Active Comparator: Entecavir 0.5 mg Entecavir 0.5 mg Intervention: Drug: Entecavir 0.5 mg Experimental: LB80380 Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study) Intervention: Drug: LB80380
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	115
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 66 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China, Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01242787
Other Study ID Numbers ^ICMJE	BVCL008
Has Data Monitoring Committee	No
Responsible Party	LG Life Sciences
Study Sponsor ^ICMJE	LG Life Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	LG Life Sciences
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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