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

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT02753699

Run by

Debiopharm International SA

People needed

723

Starts

2011-12-01

Expected to finish

2015-05-01

Last updated by the study team

2016-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provides written informed consent before any assessment is performed
• Is male or female aged ≥18
• Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
• Has achieved SVR24
• Is able to comply with the visit schedule

You may not qualify if…

• Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
• Use or planned use to start a new course of hepatitis C therapy.
• No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.

Where it is running

• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Ventura, California, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Arlington, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Salt Lake City, Utah, United States
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Kingswood, New South Wales, Australia
• Novartis Investigative Site — Kogarah, New South Wales, Australia
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Greenslopes, Queensland, Australia
• Novartis Investigative Site — Fitzroy, Victoria, Australia
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Calgary, Alberta, Canada
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Torono, Ontario, Canada
• Novartis Investigative Site — Clichy, France
• Novartis Investigative Site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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