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
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...
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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...
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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...
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Annandale, Virginia 22031
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Bronx, New York 10468
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Coronado, California 92118
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Gainesville, Florida 32610
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1101 East 33rd Street
Lutherville, Maryland 21093
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Madison, Wisconsin 53715
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New York, New York 10021
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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...
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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...
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San Antonio, Texas 78215
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San Diego, California 92105
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San Juan, 00910
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Tulsa, Oklahoma 74135
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Tulsa, Oklahoma 74137
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