EXTEND: A 3-Year, Virology, Follow-up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies

• Conditions: Hepatitis C virus infection; MedDRA version: 12.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)

• Registration Number: EUCTR2009-011464-11-DE
• Lead Sponsor: Vertex Pharamceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified