NCT00672867已完成3 期
A Open Randomized Clinical Trial Comparing the Efficacy and Safety of Clevudine 30mg Versus Adefovir 10mg in Patients With LC-B
Bukwang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR
研究概览
简要总结
The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-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.
- •5 ≦ Child-Pugh score ≦ 12
- •Patient is HBV DNA positive with DNA levels ≥ 1 x 10(4) copies/mL within 30 days of baseline.
- •Patient is documented to be HBsAg positive for > 6 months.
- •Patient is HBeAg positive or negative.
- •Patient has ALT or AST levels which are in the range of > 1 x ULN and < 15 X ULN
- •Patient with liver cirrhosis diagnosed by imaging study within 1 year or clinical evidence of portal hypertension
- •Life expectancy of at least 12 months
- •Female patient with a negative urine(Beta-HCG) pregnancy test taken within 14 days of starting therapy.
- •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.
- •Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
- •Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
- •Patient is coinfected with HCV, HDV or HIV.
- •Patient with clinical evidence of hepatocellular carcinoma
- •Patient has alpha-fetoprotein > 400ng/mL.
- •Patient has Hemoglobin <8g/dL (Male), 7.5g/dL (Female) or WBC <1,500mm3 or Neutrophils <500/mm3 or Platelet count <30,000/mm
- •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 with previous liver transplantation
- •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
干预措施: Clevudine (Drug)
2
Active Comparator
Adefovir
干预措施: Adefovir dipivoxil (Drug)
结局指标
主要结局
Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR
次要结局
- MELD score improvement
- Biochemical improvement
- The change of HBV DNA from the baseline.
- Child-Pugh score improvement
- Proportion of patients with HBeAg loss and/or seroconversion
研究者
研究点 (1)
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