Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:August 2010
End Date:May 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

The study is to investigate whether HCV GT1 patients with a history of non-response/relapse
to PegIFN + RBV benefit from treatment with triple therapy of DEB025 plus Peg-IFN and
ribavirin compared to triple treatment with placebo matching DEB025 plus Peg-IFN and
ribavirin


Inclusion criteria:

Chronic hepatitis C G1 viral infection; Plasma HCV RNA level lower limit ≥ 1,000 IU/ml
assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening, no
upper limit; HCV genotype 1; Previous non-responders/relapsers to PegIFN + RBV after
treatment for at least 12 weeks.

Exclusion criteria:

Treatment with any anti-HCV drug (whether approved or investigational) within 3 months
prior to screening; Women of child-bearing potential (WOCBP), defined as all women
physiologically capable of becoming pregnant, UNLESS they are using a highly effective
contraception; Any other cause of relevant liver disease other than HCV; Other
protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
17
sites
Novartis Investigational Site
Tampa, Florida 33613
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Novartis Investigative Site
Arlington, Texas 76012
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Arlington, TX
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Novartis Investigative Site
Bradenton, Florida 32405
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Bradenton, FL
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Novartis Investigative Site
Brooklyn, New York 11218
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Brooklyn, NY
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Novartis Investigative site
Dallas, Texas 75216
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Dallas, TX
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Novartis Investigative Site
Egg Harbor Twp, New Jersey 08234
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Egg Harbor Twp, NJ
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Novartis Investigative Site
Honolulu, Hawaii 96813
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Honolulu, HI
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Novartis Investigative Site
Houston, Texas 77030
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Houston, TX
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Novartis Investigative Site
Kingswood, New South Wales 2747
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Kingswood,
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Novartis
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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New York, NY
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Novartis Investigative Site
Orlando, Florida 32806
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Orlando, FL
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Novartis
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 Antonio, TX
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Novartis Investigative Site
San Diego, California 92123
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San Diego, CA
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Novartis Investigational Site
Springfield, Illinois 62703
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Springfield, IL
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Novartis Investigative Site
Springfield, Massachusetts 01104
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Springfield, MA
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Novartis Investigator Site
Topeka, Kansas 66606
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Topeka, KS
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Novartis Investigative Site
Ventura, California 93003
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Ventura, CA
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