NCT01264354已完成4 期
An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
Bukwang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients with HBV DNA levels < 300 copies/mL
研究概览
简要总结
This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.
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 —（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 ≥ 1×10^5 copies/mL within 30days of baseline.
- •Patient has ALT levels ≥ 1×ULN
- •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, Tenofovir or any other investigational nucleoside for HBV infection.
- •Patient with clinical evidence of decompensated liver disease (Total bilirubin < 2.0mg/dL, Prothrombin time < 1.7(INR), Serum albumin≥3.5g/dL)
- •Patient is coinfected with HCV, HDV or HIV.
- •Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- •Patient with clinical evidence of 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]
研究组 & 干预措施
1
Experimental
Clevudine 30mg
干预措施: Clevudine 30mg (Drug)
2
Experimental
Clevudine 20mg+Adefovir dipivoxil 10mg
干预措施: Clevudine 20mg+Adefovir dipivoxil 10mg (Drug)
3
Experimental
Clevudine 20mg
干预措施: Clevudine 20mg (Drug)
结局指标
主要结局
Proportion of patients with HBV DNA levels < 300 copies/mL
时间窗: 24 week
次要结局
- The change of HBV DNA form the baseline(24week, 48week, 96week)
- Proportion of patients with HBV DNA < 300 copies/mL(48week, 96week)
- Proportion of patients with ALT normalization(24week, 48week, 96week)
- Proportion of patients with HBeAg loss and/or seroconversion(96 Week)
研究者
研究点 (1)
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