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 |
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
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
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
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University of Michigan Health System The University of Michigan is home to one of the...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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