NCT00641082已完成4 期
A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
Bukwang Pharmaceutical2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2008年2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
- 43
- 试验地点
- 2
- 主要终点
- Proportion of patients with HBV DNA below 300copies/mL
研究概览
简要总结
A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 60
- •Patient is documented to be HBsAg positive for > 6 months.
- •Patient with compensated hepatic function.
- •Nucleoside treatment-naÃ-ve subjects of either gender
- •Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(5) copies/mL within 30 days of baseline.
- •Patient has ALT levels which are in the range of 2 x ULN and < 10 X ULN
- •Patient who has not a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- •Exclusion Criteria
- •Patient is currently receiving antiviral or corticosteroid therapy.
- •Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, famciclovir or any other investigational nucleoside for HBV infection.
- •Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
- •Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
- •Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit.
- •Patient is coinfected with HCV, HDV or HIV.
- •Patient with following clinical evidence
- •Decompensated liver cirrhosis (Child class B,C: CPT score 7) or hepatocellular carcinoma
- •Significant gastrointestinal, renal, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease
- •Previous organ transplantation
- •Patient has a clinically relevant history of abuse of alcohol or drugs.
- •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 α-Fetoprotein more than 100ng/mL
- •Patient has Hemoglobin <11g/dL (Male), 10g/dL (Female) or WBC count < 3,500/mm3 (PMN<1,500/mm3) or Platelet count <50,000/mm3
- •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]
排除标准
- 未提供
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 300copies/mL
时间窗: at week 48
次要结局
- The change of HBV DNA from the baseline(at week 24, 48)
- Proportion of patients with HBV DNA below LOD of RT-PCR(at week 24, 48)
- ALT normalization rate(at week 24, 48)
- Proportion of patients with viral breakthrough during 48-week treatment period(at week 24, 48)
研究者
研究点 (2)
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