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 - Prove 3 rollover

Vertex Pharmaceuticals0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方: Vertex Pharmaceuticals
入组人数: 5

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

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.

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

发起方

Vertex Pharmaceuticals

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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 ResponseMedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis CHepatitis C

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