3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study

• Status: Terminated
• Trial end date: 2014-01-23
• Target enrollment: 0
• Participant gender: All

Summary

Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

1. Males or females aged ≥18

2. Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)

3. Have not achieved SVR24

Exclusion Criteria:

1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.

2. Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study