跳至主要内容
临床试验/NCT02004379
NCT02004379已完成不适用

Register of Telaprevir and Boceprevir in Routine Clinical Practice

Fundación Pública Andaluza Progreso y Salud47 个研究点 分布在 1 个国家目标入组 1,553 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,553
试验地点
47
主要终点
Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated

研究概览

简要总结

Know through routine clinical practice the effectiveness and safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients infected by hepatitis C virus, genotype 1
  • Indication of treatment with telaprevir or boceprevir in F3 and F4 fibrosis

排除标准

  • Being taking part in other
  • Inability to follow a monitoring
  • Contra-indications on triple therapy
  • Coinfected with HIV and HBV (hepatitis B virus)

结局指标

主要结局

Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated

时间窗: 12 months

Number and frequencies of serious adverse event (SAE) during the treatment

Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated

时间窗: 12 months

Know through routine clinical practice the percentage of patients who have negative VHC-ARN

次要结局

未报告次要终点

研究者

发起方
Fundación Pública Andaluza Progreso y Salud
申办方类型
Other
责任方
Sponsor

研究点 (47)

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