Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

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

Details

• Lead Sponsor: Debiopharm International SA

Criteria

Inclusion Criteria:

1. Provides written informed consent before any assessment is performed

2. Is male or female aged ≥18

3. Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir

4. Has achieved SVR24

5. Is able to comply with the visit schedule

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. Use or planned use to start a new course of hepatitis C therapy.

3. No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.