NCT01264133终止4 期
An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With Chronic Hepatitis B
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9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 levels < 60 IU/mL
研究概览
简要总结
An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with chronic hepatitis B.
研究设计
- 研究类型
- Interventional
- 干预模型
- Factorial
- 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.
- •Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
- •Patient has ALT levels >=80 IU/L
- •Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis <= 6)
- •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, peg-interferon or other immunomodulatory within the previous 6 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 has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- •Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
- •Patient with previous liver transplantation
- •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 levels < 60 IU/mL
时间窗: 48 week
次要结局
未报告次要终点
研究者
研究点 (2)
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