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临床试验/NCT00262483
NCT00262483已完成2 期

A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C

Vertex Pharmaceuticals Incorporated2 个研究点 分布在 2 个国家目标入组 12 人开始时间: 2005年12月1日最近更新:
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适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
12
试验地点
2
主要终点
Safety of triple combination therapy.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Infected with hepatitis C virus

排除标准

  • •Contraindications to peginterferon or ribavirin therapy.

结局指标

主要结局

Safety of triple combination therapy.

时间窗: retrospective and prospective

次要结局

  • Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin.(retrospective and prospective)
  • Plasma HCV RNA levels(retrospective and prospective)

研究者

申办方类型
Industry

研究点 (2)

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A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects with Hepatitis C - Phase2 Study of VX-950,Pegasys(peginterferon alfa-2a,Peg-IFN) & Copegus(ribavirin,RBV) in HepatitisCHepatitis C virus (HCV) infectionMedDRA version: 8.1Level: LLTClassification code 10019744Term: Hepatitis C
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