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

Phase 1

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

• Registration Number: EUCTR2006-005123-42-FR
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-19
• Study Completion: 2010-02-26
• Last Update Posted: 8 October 2021

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.
- 3.Subjects must agree to use 2 non-hormonal methods of contraception that are highly effective, with one or both being barrier methods (for example a condom in combination with an IUD, or a condom in combination with a diaphragm and spermicide). It is uncertain how much the effectiveness of hormonal contraceptives may be reduced whilst taking telaprevir, therefore, female patients who are already taking a hormonal contraceptive may continue to use that method, but also use two non-hormonal methods, as described above, for the duration of telaprevir treatment and for two months after the last dose. 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 7 months 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.

Female subjects of childbearing potential must have a negative pregnancy test at all visits before the first dose and during the dosing period. (Note: For female partners of male subjects, pregnancy testing cannot be mandated because the partners are not study participants. However, monthly pregnancy testing until 7 months after the male’s last dose of RBV is strongly recommended, in accordance with the product labeling for RBV.)

- 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 sig

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 of the protocol within 30 days of Day 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified