E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C Virus Infection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019744 |
E.1.2 | Term | Hepatitis C |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide access to a telaprevir-based treatment to subjects enrolled in the Peg IFN alfa-2a plus ribavirin Control Group (Group A) of Studies VX06 950-106 (Study 106), VX05-950-104 (Study 104) or VX05 950 104EU (Study 104EU) who stopped treatment due to inadequate response to treatment, or who relapsed after treatment.
To demonstrate the efficacy of telaprevir in combination with Peg IFN alfa-2a and RBV in treatment-experienced subjects with genotype 1 chronic HCV.
To evaluate safety of telaprevir in combination with Peg IFN alfa-2a and RBV in treatment-experienced subjects with genotype 1 chronic HCV.
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E.2.2 | Secondary objectives of the trial |
To perform intrasubject comparisons of antiviral response to telaprevir, Peg IFN alfa-2a, and RBV treatment with the antiviral response to prior Peg IFN alfa-2a and RBV treatment.
To determine the antiviral response to telaprevir, Peg IFN alfa-2a, and RBV treatment in subjects characterized as null responders, partial responders, having viral breakthrough, or relapsers during prior treatment with Peg IFN alfa-2a, and RBV in the 104, 104EU, or 106 study.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with undetectable HCV RNA 24 weeks after the completion of treatment.
Adverse events and clinical laboratory assessments. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |