Virology Follow up Study in Subjects Previously Treated With Telaprevir

Vertex Pharmaceuticals

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: telaprevir

Study type: Observational

Funder types: Industry

Identifiers

NCT00916474

VX08-950-112

Details and patient eligibility

About

Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.

Enrollment: 408 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

408 participants in 2 patient groups

Cohort A

Description:

Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time

Treatment:

Drug: telaprevir

Cohort B

Description:

Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time

Treatment:

Drug: telaprevir