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临床试验/JPRN-UMIN000009656
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Therapeutic drug monitoring of telaprevir in chronic hepatitis C patients receiving telaprevir -based triple therapy is useful for predicting virological response. - Plasma telaprevir concentrations in chronic hepatitis C patients receiving telaprevir -based triple therapy

Kyushu University Hospital0 个研究点目标入组 70 人开始时间: 2012年12月28日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
70

研究概览

简要总结

The rates of undetectable HCV RNA at week 4 (RVR) and at 24 weeks after therapy (sustained virological response: SVR) were 71.4% and 82.9%, respectively. Of patients with RVR, 90% achieved an SVR. The mean TVR C-troughs at days 3 and 7 and weeks 2 and 8 of SVR patients (2748.2, 2733.7, 2999.0, and 2937.8 ng/mL, respectively) was significantly higher than that of non-SVR patients (1616.4, 1788.0, 2314.4, and 2691.1 ng/mL, respectively) (all P<0.05). Multiple logistic regression analysis identified two factors: higher TVR C-trough at day 3 (ng/mL) (odds ratio 1.012, P<0.0001) and prior treatment relapse (odds ratio 6.16 for prior null response, P<0.0001).

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • Exclusion criteria were: (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (2) clinical or biochemical evidence of hepatic decompensation (ascites, bleeding varices, or encephalopathy); (3) other causes of liver disease (autoimmune hepatitis, primary biliary cirrhosis, or steatohepatitis); (4) excessive active alcohol consumption (a daily intake of more than 40 g of ethanol) or drug abuse; (5) suspected HCC at entry; or (6) treatment with antiviral or immunosuppressive agents prior to enrollment.

研究者

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