Hepatitis C virus infection MedDRA version: 12.0 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV)
Conditions
Interventions
Product Name: telaprevir
Product Code: VX-950
Pharmaceutical Form: Tablet
INN or Proposed INN: telaprevir
CAS Number: 402957-28-2
Current Sponsor code: VX-950
Sponsors
Vertex Pharamceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject must: 1. Have received at least 1 dose of telaprevir-based treatment in 1 of the following clinical studies: VX05-950-104, VX05-950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, or VX-950-TiDP24-C216. 2. Have baseline HCV viral sequencing data available from previous telaprevir study. 3. Be able and willing to give informed consent to participate in the study. 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
Exclusion criteria: The subject must not: 1. Be currently participating in the antiviral follow-up period of an ongoing telaprevir trial. (Note: Subjects who have completed the required antiviral follow-up period but are still participating in the collection of patient reported outcomes data for their previous telaprevir study may be eligible.) 2. For subjects participating in ongoing studies at the time of enrollment, have more than 90 elapsed days between the database lock or unblinding in the previous telaprevir study and Day 1 in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cohort A: To assess the durability of virologic response in subjects who achieved an SVR following telaprevir-based treatment in a previous study Cohort B: To evaluate changes in HCV variants over time in subjects who did not achieve an SVR following telaprevirbased treatment in a previous study;Secondary Objective: Cohort A: To evaluate HCV variants in subjects with late relapse following telaprevir-based treatment in a previous study To evaluate the incidence of safety outcomes related to severe liver disease in subjects following telaprevir-based treatment in a previous study (Note: Late relapse is defined as detectable HCV RNA [>10 IU/mL] in a subject who had achieved SVR as defined in the previous telaprevir study. See Section 12.2.4.4 for a complete definition.) Cohort B: To evaluate the incidence of safety outcomes related to severe liver disease in subjects following telaprevir-based treatment in a previous study;Primary end point(s): Cohort A: Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment Cohort B: Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment | — |
Countries
France, Germany
Outcome results
None listed