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

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

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
4717
mi
from
Clichy,
Click here to add this to my saved trials
Arlington, Texas 76012
347
mi
from
Arlington, TX
Click here to add this to my saved trials
Bakersfield, California 93301
1184
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Houston, Texas 77030
572
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
572
mi
from
Houston, TX
Click here to add this to my saved trials
Lancaster, California 93534
1149
mi
from
Lancaster, CA
Click here to add this to my saved trials
Newport News, Virginia 23606
1167
mi
from
Newport News, VA
Click here to add this to my saved trials
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
576
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
1138
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92123
1138
mi
from
San Diego, CA
Click here to add this to my saved trials
Seattle, Washington 98103
1412
mi
from
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98103
1412
mi
from
Seattle, WA
Click here to add this to my saved trials
St. Louis, Missouri 63110
415
mi
from
St. Louis, MO
Click here to add this to my saved trials