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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Percentage of patients showing HBV DNA mutation
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who are able to participate in this expanded study without any interruption after completing 48 weeks treatment of LG-BVCL007 study
排除标准
- •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
研究组 & 干预措施
Entecavir 0.5 mg
Entecavir 0.5 mg
干预措施: Entecavir 0.5 mg (Drug)
LB80380
Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)
干预措施: LB80380 (Drug)
结局指标
主要结局
Percentage of patients showing HBV DNA mutation
时间窗: at Week 48
Safety assessment including adverse events, laboratory abnormalities and DNA mutation
次要结局
- Change of HBV DNA from Baseline of LG-BVCL007 study(at Week 48)