A Phase 2 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, VX05-950-104 and VX05-950-104EU Who did not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response - Rollover Study of Telaprevir (VX-950), Pegasys, and Copegus in Hepatitis C

Conditions: Hepatitis C virus (HCV) infection
MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

Registration Number: EUCTR2006-005123-42-AT

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 170

Inclusion Criteria

- Subjects randomized in the Peg-IFN-alfa plus ribavirin control arm (Group A) of Study VX06-950-106, study VX05-950-104 or Study VX05-950-104EU are eligible to participate. Subjects from Study VX06-950-106 must enter the study only after week 24 and within 72 weeks of taking their first dose of study drug in the parent study. subjects from study VX05-950-104 and VX05-950-104EU should enter this study as soon as possible and within 76 weeks of taking their first dose of study drug in the parent study.
- Subjects must have discontinued treatment in the parent study based on the following criteria: All subjects:
• 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. VX06-950-106 subjects only: Week 4 Nonresponder, defined as not having a =1-log10 decrease from baseline in HCV RNA.
- The screening visit laboratory values must be within the central laboratory reference ranges outlined in the protocol.
- Subjects must agree to use 2 non-hormonal methods of contraception that are highly effective, with one being a barrier method, (e.g. condom or diaphragm with spermicidal jelly) during telaprevir treatment and 2 months after the last dose of telaprevir. Once treatment with telaprevir is completed, subjects must continue to use 2 efficient methods of contraception for an additional month, (i.e., total of 90 days including 2 non-hormonal methods for the first 2 months of those 90 days), and in line with RBV’s package insert, until 24 weeks after the last dose of RBV have elapsed. Female subjects and female partners of male subjects must use the same precautions. Male subjects must not father a child while on study and for 24 weeks after the last dose of the study medication.
- 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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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