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

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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
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...
1263
mi
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South Miami, FL
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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...
643
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Ann Arbor, MI
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Annandale, Virginia 22031
403
mi
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Annandale, VA
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1755
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Aurora, CO
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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...
357
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Baltimore, MD
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Bronx, New York 10468
177
mi
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Bronx, NY
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Coronado, California 92118
2578
mi
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Coronado, CA
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Gainesville, Florida 32610
1076
mi
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Gainesville, FL
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1101 East 33rd Street
Lutherville, Maryland 21093
355
mi
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Lutherville, MD
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Madison, Wisconsin 53715
928
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Madison, WI
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New York, New York 10021
184
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New York, NY
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
1112
mi
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Orlando, FL
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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...
270
mi
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Philadelphia, PA
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San Antonio, Texas 78215
1761
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San Antonio, TX
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San Diego, California 92105
2572
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San Diego, CA
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San Juan, 00910
1678
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San Juan,
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Tulsa, Oklahoma 74135
1391
mi
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Tulsa, OK
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Tulsa, Oklahoma 74137
1393
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Tulsa, OK
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