Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
This trial is active, not recruiting.
|Condition||chronic hepatitis b|
|Treatments||lb80380, entecavir 0.5 mg|
|Sponsor||LG Life Sciences|
|Start date||August 2010|
|End date||September 2012|
|Trial size||115 participants|
|Trial identifier||NCT01242787, BVCL008|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Percentage of patients showing HBV DNA mutation
time frame: at Week 48
Change of HBV DNA from Baseline of LG-BVCL007 study
time frame: at Week 48
Male or female participants from 18 years up to 66 years old.
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
|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|
|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|
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