Hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide access to a telaprevir-based treatment to subjects of the Control Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate response to treatment (according to treatment stopping rules). Safety, tolerability, and HCV RNA levels will be collected. Study VX06-950-106 is being submitted under a separate CTA (EudraCT # 2006-004665-33);Secondary Objective: ;Primary end point(s): Primary Endpoint: - Plasma HCV RNA response to telaprevir treatment Secondary endpoints: - Adverse events and clinical laboratory assessments, including ALT and other liver function tests. - Genotypic and phenotypic analyses of the NS3•4A HCV region. - Pharmacokinetic assessments of telaprevir, Peg-IFN-a-2a, and RBV | — |
Countries
Austria, France, Germany, Netherlands, United Kingdom
Outcome results
None listed