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

Stopped early · Phase 3

Conditions studied: Hepatitis C, Chronic

In brief

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

Key facts

Study ID

NCT02465203

Run by

Novartis Pharmaceuticals

People needed

105

Starts

2012-09-06

Expected to finish

2014-01-23

Last updated by the study team

2018-01-12

Who can join

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

You may qualify if…

• Males or females aged ≥18
• Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)
• Have not achieved SVR24

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

Where it is running

• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Ventura, California, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Arlington, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Torono, Ontario, Canada
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Freiburg im Breisgau, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Kiel, Germany
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Mumbai, Maharashtra, India
• Novartis Investigative Site — Parma, PR, Italy
• Novartis Investigative Site — Pavia, PV, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Torino, TO, Italy
• Novartis Investigative Site — Bialystok, Poland
• Novartis Investigative Site — Warsaw, Poland
• Novartis Investigative Site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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