VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Infectious Diseases BVBA
• Collaborator: Vertex Pharmaceuticals Incorporated
• Treatments: Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Patient from the control group of the C216 study who failed therapy for virologic reasons

• Patient must have completed all assessments in the C216 trial

• Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

• Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial

• Patient has history of decompensated liver disease

• Patient has history of acute or chronic pancreatitis

• Patient has condition that requires use of systemic corticosteroids

• Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment

• Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma