NCT01263002已完成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 Associated Hepatocellular Carcinoma
Bukwang Pharmaceutical2 个研究点 分布在 2 个国家目标入组 33 人开始时间: 2010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
- 33
- 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 of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma
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 with chronic HBV DNA and/or with symptoms of liver cirrhosis
- •Patient with Hepatocellular carcinoma evidenced by sonography, CT scan, or MRI scan)
- •Patient is 18 years and older.
- •Patient is documented to be HBsAg positive for > 6 months.
- •Laboratory report proving HBsAg positive or HBeAg positive for at least six months
- •IgM anti-HBc negative, IgG anti-HBc positive at screening
- •Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
- •Patient has ALT or AST levels >=40 IU/L
- •Cell carcinoma/hepatocellular carcinoma patient who is anticipated to live at least 1 year.
- •Patient who is fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- •Patient who is classified as NYHA functional classification grade 1-
- •(NYHA;New York Heart Association)
- •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 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, tenofovir or any other investigational nucleoside for HBV infection.
- •Patient is coinfected with HCV, HDV or HIV.
- •Patient with metastatic malignancy.
- •Patient with previous liver transplantation
- •Patient is pregnant or breast-feeding.
- •Patient has a clinically relevant history of abuse of alcohol or drugs.
- •Patient use oriental medicine within the previous 2 weeks.
- •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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