Hepatitis C
Conditions
Brief summary
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.
Interventions
DRUGtelaprevir
Sponsors
Tibotec Pharmaceutical Limited
Vertex Pharmaceuticals Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Have baseline HCV viral sequencing data available from previous telaprevir study
Exclusion criteria
* May not 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.) * 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 |
|---|---|
| Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment | 3 years |
| Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse | 3 years |
Countries
Canada, France, Germany, Puerto Rico, United States
Outcome results
None listed