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

Use our guide to learn which trials are right for you!

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
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Novartis Investigative Site
Arlington, Texas 76012
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Novartis Investigative Site
Bradenton, Florida 32405
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Novartis Investigative Site
Brooklyn, New York 11218
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Novartis Investigative site
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Novartis Investigative Site
Egg Harbor Twp, New Jersey 08234
?
mi
from
Egg Harbor Twp, NJ
Click here to add this to my saved trials
Novartis Investigative Site
Honolulu, Hawaii 96813
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Novartis Investigative Site
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Novartis Investigative Site
Kingswood, New South Wales 2747
?
mi
from
Kingswood,
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Novartis Investigative Site
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Novartis Investigative Site
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Novartis Investigational Site
Springfield, Illinois 62703
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Novartis Investigative Site
Springfield, Massachusetts 01104
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Novartis Investigational Site
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Novartis Investigator Site
Topeka, Kansas 66606
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Novartis Investigative Site
Ventura, California 93003
?
mi
from
Ventura, CA
Click here to add this to my saved trials