Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:June 2011
End Date:October 2013

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

Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3

The purpose of the study is to determine whether therapy with the combination of PSI-7977
and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C
virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic
response with undetectable HCV RNA 12 weeks post treatment


Inclusion Criteria:

- Men and women, ages 18 to 70 years.

- Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no
previous exposure to an interferon formulation (ie, interferon-alpha, pegylated
interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including
daclatasvir and PSI-7977).

- Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by:
positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6
months prior to screening, and HCV RNA and anti-HCV antibody at the time of
screening.

Exclusion Criteria:

- Evidence of a medical condition associate with chronic liver disease other than HCV.

- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management
with diuretics or paracentesis.

- History of hemophilia.

- History of torsade de pointes.

- Current or known history of cancer (except in situ carcinoma of the cervix or
adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
to enrollment.

- History of gastrointestinal disease or surgical procedure (except cholecystectomy).

- History of clinically significant cardiac disease.

- Blood transfusion within 4 weeks prior to study drug administration.

- Poor venous access.

- Any other medical, psychiatric, and/or social reason which, in the opinion of the
Investigator, would make the candidate inappropriate for participation in this study.
We found this trial at
18
sites
Bronx, New York 10468
?
mi
from
Bronx, NY
Click here to add this to my saved trials
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
?
mi
from
South Miami, FL
Click here to add this to my saved trials
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Annandale, Virginia 22031
?
mi
from
Annandale, VA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Coronado, California 92118
?
mi
from
Coronado, CA
Click here to add this to my saved trials
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
1101 East 33rd Street
Lutherville, Maryland 21093
?
mi
from
Lutherville, MD
Click here to add this to my saved trials
Madison, Wisconsin 53715
?
mi
from
Madison, WI
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92105
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Juan, 00910
?
mi
from
San Juan,
Click here to add this to my saved trials
Tulsa, Oklahoma 74135
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Tulsa, Oklahoma 74137
?
mi
from
Tulsa, OK
Click here to add this to my saved trials