NCT01026610已完成2 期
A Phase IIb, Open, Multinational, Multi-center, Randomised, Comparative, Parallel Study to Assess the Safety and Antiviral Activity of LB80380 Compared to Entecavir 0.5 mg in Chronic Hepatitis B Patients for 48 Weeks With a Planned Analysis of Efficacy and Safety at Week 24 of the Treatment for Selecting Optimal Dose
LG Life Sciences10 个研究点 分布在 2 个国家目标入组 115 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 10
- 主要终点
- Changes in HBV DNA level (log10) from baseline
研究概览
简要总结
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 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 HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.
In this study, the treatment period 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male, 18 to 65 years of age, inclusive
- •Chronic hepatitis B
- •Not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before Screening
- •Not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within Screening
- •Compensated chronic hepatitis B
- •HBeAg positive or HBeAg negative
- •Elevated serum ALT level (1.2-10 X ULN, inclusive)
排除标准
- •Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
- •Decompensated liver disease
- •Creatinine clearance (calculated by Cockroft-Gault formula) less than 50 ml/min
- •Screening 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
- •A history of organ transplantation
- •Presence of anti-HBs at screening
研究组 & 干预措施
LB80380 150 mg
Experimental
LB80380 150 mg (60 mg + 90 mg), once daily oral dose
干预措施: LB80380 150 mg (Drug)
LB80380 90 mg
Experimental
LB80380 90 mg (90 mg + placebo), once daily oral dose
干预措施: LB80380 90 mg (Drug)
entecavir 0.5 mg
Active Comparator
entecavir 0.5 mg, once daily oral dose
干预措施: entecavir 0.5 mg (Drug)
结局指标
主要结局
Changes in HBV DNA level (log10) from baseline
时间窗: At Week 24
次要结局
- Proportion of patients with undetectable serum HBV DNA(At Week 24 or Week 48)
- Proportion of patients with HBeAg seroconversion(At Week 24 or Week 48)
- Proportion of patients with ALT normalization(At Week 24 or Week 48)
- Safety assessment during the whole study period(At Week 24 or Week 48)
研究者
研究点 (10)
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