NCT01264094终止4 期
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
Bukwang Pharmaceutical2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2009年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of patients with HBV DNA below the assay limit of detection
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years and older.
- •Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive.
- •Patient is HBeAg positive or negative.
- •Patient has ALT levels ≥ 80 IU/L
- •Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
排除标准
- •Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- •Patients previously treated with interferon within the previous 3 months.
- •Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- •Patient is coinfected with HCV, HDV or HIV.
- •Patient is pregnant or breast-feeding.
- •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
次要结局
- The change of HBV DNA from the baseline.
- Biochemical improvement (e.g. ALT normalization).
- Proportion of patients with HBeAg loss and/or seroconversion.
- Proportion of sAg loss
研究者
研究点 (2)
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