Alisporivir With pegIFN/RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C



Status:Terminated
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:February 2012
End Date:February 2014

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A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1

The purpose of this study is to evaluate the overall efficacy, and safety profile, of triple
combination therapy of DEB025/pegIFN/RBV in chronic hepatitis C patients who failed prior
treatment with PI.


Inclusion criteria:

1. HCV GT1 patients with previous PI treatment failure.

2. Timing of the PI treatment. the minimum time from the last dose of previous PI
treatment to the first dose of study medication is three months.

3. Diagnosed Chronic hepatitis C virus infection

4. Infection with HCV genotype 1

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment,

2. History of hypersensitivity to any pegIFN or RBV.

3. Any null non-responders to prior pegIFN/RBV treatment,

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
23
sites
Sacramento, California 95825
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Alexandria, Virginia 22310
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Arlington, Texas 76012
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Bakersfield, California 93301
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Baltimore, Maryland 21287
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Bradenton, Florida 32405
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Brockton, Massachusetts 02301
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Chicago, Illinois 60612
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Cincinnati, Ohio 45229
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Dallas, Texas 75216
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Los Angeles, California 90095
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Miami, Florida 33136
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Minneapolis, Minnesota 55402
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Newport News, Virginia 23606
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Palo Alto, California 94304
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Phoenix, Arizona 85012
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Providence, Rhode Island 02908
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San Diego, California 92123
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St. Louis, Missouri 63110
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Vancouver, British Columbia
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Ventura, California 93003
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Wellington, Florida 33449
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