EUCTR2006-005123-42-NL进行中（未招募）1 期
A Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106 Who did not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subjects randomized in the control arm (Group A) of Study VX06-950-106 are eligible to participate. In addition, these subjects must have discontinued treatment in that study because of the following criteria:
- •Week 4 Nonresponder, defined as not having a > or = 1-log10 decrease from baseline in HCV RNA.
- •Viral breakthrough between Week 4 and Week 24. Subjects discontinued study treatment if, on 2 consecutive occasions, the results of HCV RNA testing indicated viral breakthrough. Viral breakthrough is defined as (1) an increase in HCV RNA of >1 log10 compared to the lowest recorded on-treatment value or (2) an HCV RNA level of >100 IU/mL in a subject who had undetectable HCV RNA at a prior time point.
- •Week 12 (EVR) Nonresponder, defined as not having achieved an early viral response (EVR, a =2 log10 reduction from baseline in HCV RNA).
- •Week 24 Nonresponder, defined as subjects who had detectable HCV RNA at Week 24.
- •Week 26 to Week 48 Nonresponder; defined as subjects who had detectable HCV RNA between Weeks 26 and 48.
- •Subjects who had detectable HCV RNA during the 24-week post-treatment period.
- •- Subjects must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the last dose of study drug. Female subjects of childbearing potential must have a negative pregnancy test at all visits prior to the first dose.
- •- Subjects must be willing to refrain from the concomitant use of any medications, substances or foods noted in Section 18 of the protocol.
- •- Subjects must be able to read and understand the Informed Consent Form (ICF) and willing to sign the ICF and abide by the study restrictions.
- •- Subjects must agree not to participate in other clinical studies for the duration of their participation in this trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subjects who discontinued prior Peg-IFN or RBV for adverse events or for any other reason other than failure to respond to therapy and for whom repeated treatment would be inappropriate.
- •- Women who are pregnant or breast-feeding.
- •- Male partners of women who are pregnant or breast-feeding.
- •- Subjects who have taken any of the prohibited medications identified in Section 18 within 30 days of Day 1.
研究者
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