NCT01266005终止4 期
A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients
Bukwang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2009年8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
- 终止
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Intrahepatic cccDNA reduction from baseline
研究概览
简要总结
This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.
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 who is older than
- •Patient who is HBsAg positive for the previous 6 months and with HBV DNA ≥ 1 x 10^5 copies/mL
- •Patient who is HBeAg negative.
- •Patient with ALT≥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.
- •Patient is treated with interferon for the previous 6 months.
- •Patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- •Patient is coinfected with HCV, HDV or HIV.
- •Patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy.
- •Patient has evidence of decompensated Liver cirrhosis and/or hepatocellular carcinoma.
- •Patient has a history of organ transplantation.
- •Patient has the treatment of nephrotoxicity drugs, competitive drugs for kidney to excrete, and/or hepatotoxicity drugs for the previous 2 months from screening.
- •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, allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
- •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 (Drug)
2
Active Comparator
Entecavir 0.5mg
干预措施: Entecavir (Drug)
结局指标
主要结局
Intrahepatic cccDNA reduction from baseline
时间窗: week 48
次要结局
- Proportion of patients with HBV DNA below LOD by real-time PCR(day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks))
- Reduction of HBV DNA level from baseline(day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks))
- ALT normalization(day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks))
- Reduction of sAg titer from baseline(day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks))
- Proportion of maintaining sustained effect(every 8 weeks during follow-up period(48weeks))
研究者
研究点 (1)
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