Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon



Status:Completed
Conditions:Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2014
End Date:April 2015

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A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.

This study will explore the relationship of different DEB025 doses in combination with RBV
to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in
chronic hepatitis C GT 2 and 3 patients who have previously failed interferon therapy or are
intolerant or unable to take interferon


Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.

2. HCV G2/3 patients who have previously failed interferon therapy or are intolerant or
unable to take interferon.

3. Males or females aged ≥18 years.

4. Chronic hepatitis C virus infection diagnosed.

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5
half-lives of that medication before enrollment.

2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes

3. HBsAg positive

4. HIV positive.

Other protocol-defined inclusion/exclusion criteria apply.
We found this trial at
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San Diego, California 92123
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Arlington, Texas 76012
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Bakersfield, California 93301
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Clichy,
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, TX
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Lancaster, California 93534
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Lancaster, CA
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Newport News, Virginia 23606
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Newport News, VA
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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San Diego, California 92123
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Seattle, Washington 98103
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Seattle, WA
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Seattle, Washington 98103
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Seattle, WA
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St. Louis, Missouri 63110
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St. Louis, MO
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