JPRN-UMIN000006758已完成2 期
Randomised study assessing efficacy and safety of telaprevir evey 8 or 12 hours with peginterferon alfa 2b and ribavirin in HCV patients - Study of telaprevir evey 8 or 12 hours
Hiroshima liver study group0 个研究点目标入组 50 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
SVR12 rates were 92.3% (24/26) for both q8h and q12h. The changes in mean log10 HCV RNA levels and viral response were also similar in q8h compared to q12h, whereas pharmacokinetic properties such as Cmax, AUC0-24h and Ctrough of TVR were slightly higher in q8h than in q12h (P>0.2). The frequency of TVR discontinuation due to anemia or renal damage was significantly higher in q12h than in q8h (6/26(23%) vs. 0/20, respectively; P=0.02). Antivir Ther. 2013 Nov 5. doi: 10.3851
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Patients receiving shosaiko-to 2)Autoimmune hepatitis 3)History of hypersensitivity to PEG-IFN alpha-2b and telaprevir 4)History of hypersensitivity to biological products such as vaccine 5)Decompenstated liver cirrhosis 6)HCC, malignat tumor 7)With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 8)Pregnant or lactating women and women who may be pregnant 9)Judged by investigator not to be appropriate for inclusion in this study
研究者
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