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 |
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
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
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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