NCT00558493已完成4 期
Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment
Bukwang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年11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
- 100
- 试验地点
- 1
研究概览
简要总结
A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBV DNA > 2,000 copies/mL at screening
- •Patients who have compensated liver disease (Child-Pugh score =<6)
- •Patients without LMV resistant mutation by RFMP assay
- •Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
- •Patients who can submit the written consent and comply with the claims postulated of this clinical trial
排除标准
- •Currently receiving antiviral except LMV or corticosteroid therapy
- •Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months
- •Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
- •Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
- •Patients who is co-infected with HCV, HDV or HIV
- •Serious concurrent medical conditions
- •Prior organ transplantation
- •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
switching treatment from lamivudine to clevudine
干预措施: Clevudine (Drug)
研究者
研究点 (1)
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