Ph IIA Study (SOC +/- NS5B)



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:October 2010
End Date:November 2012

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A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and
efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the
treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1
subjects


Inclusion Criteria:

- Subjects chronically infected with HCV genotype 1 as documented by: positive for
anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior
to Screening, and positive for HCV RNA and anti-HCV antibody at Screening

- HCV RNA ≥ 10*5* IU/mL at Screening

- Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a),
or RBV and no exposure to IFN or RBV within 24 weeks of Randomization

- Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence
of cirrhosis

- Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²
at Screening

Exclusion Criteria:

- Liver transplant recipients

- Documented or suspected HCC by imaging or liver biopsy

- Evidence of a medical condition associated with chronic liver disease other than HCV
(such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver
disease, alcoholic liver disease, toxin exposures)

- History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg.
HBsAg-seropositive). Patients with resolved HBV infection may participate (eg.
HBsAb-seropositive)

- 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
We found this trial at
10
sites
Arlington, Texas 76012
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Arlington, TX
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Anaheim, California 92801
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Anaheim, CA
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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...
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Baltimore, MD
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Baltimore, Maryland 21229
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Baltimore, MD
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Charlotte, North Carolina 28207
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Charlotte, NC
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Fairfax, Virginia 22031
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Fairfax, VA
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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San Antonio, Texas 78215
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San Antonio, TX
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Springfield, Massachusetts 01105
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Springfield, MA
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Tulsa, Oklahoma 74137
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Tulsa, OK
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