Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

Stopped early · Phase 3

Conditions studied: Hepatitis C

In brief

This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).

Key facts

Study ID

NCT01500772

Run by

Debiopharm International SA

People needed

6

Starts

2012-03-01

Expected to finish

2012-05-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with chronic HCV genotype 1 infection with previous PI treatment failure
• Three months minimum time from the last dose of previous PI treatment to the first dose of study medication

You may not qualify if…

• Use of other investigational drugs at the time of enrollment
• History of hypersensitivity to PEG or RBV
• Any null non-responders to prior PEG/RBV treatment
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Bakersfield, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Palo Alto, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Ventura, California, United States
• Novartis Investigational site — Bradenton, Florida, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Wellington, Florida, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Brockton, Massachusetts, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Providence, Rhode Island, United States
• Novartis Investigative Site — Arlington, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Alexandria, Virginia, United States
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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