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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by LG Life Sciences.
Recruitment status was  Active, not recruiting
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

November 12, 2010
April 13, 2012
August 2010
September 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01242787 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
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

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
115
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 66 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of
 
NCT01242787
BVCL008
No
LG Life Sciences
LG Life Sciences
Not Provided
Not Provided
LG Life Sciences
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP