NCT00558818已完成4 期
A Phase lV Study to Evaluate the Long-term Safety and Efficacy of Clevudine in the Patients Chronically Infected With Hepatitis B Virus
Bukwang Pharmaceutical2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2007年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR
研究概览
简要总结
A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with DNA levels >=1 x 10^5 copies/mL within 30 days of baseline.
- •Patient is documented to be HBsAg positive for > 6 months.
- •Patient has ALT levels >=80 IU/L
- •Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
排除标准
- •Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- •Patients previously treated with interferon within the previous 6 months.
- •Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- •Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- •Patient is coinfected with HCV, HDV or HIV.
- •Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
- •Patient is pregnant or breast-feeding.
- •Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
- •Patient has a clinically relevant history of abuse of alcohol or drugs.
- •Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
- •Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
结局指标
主要结局
Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR
时间窗: Screening, day1,every 12 weeks during treatment period(96weeks)
次要结局
- Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation(Screening, day1, every 12 weeks during treatment period(96 weeks))
研究者
研究点 (2)
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