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
13
sites
Arlington, Texas 76012
1667
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Arlington, TX
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Bakersfield, California 93301
863
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Bakersfield, CA
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4991
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Clichy,
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
1892
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Houston, TX
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Lancaster, California 93534
919
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Lancaster, CA
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Newport News, Virginia 23606
2412
mi
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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...
1786
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San Antonio, TX
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San Diego, California 92123
1059
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San Diego, CA
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San Diego, California 92123
1059
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San Diego, CA
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Seattle, Washington 98103
1
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Seattle, WA
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Seattle, Washington 98103
1
mi
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Seattle, WA
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St. Louis, Missouri 63110
1718
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St. Louis, MO
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