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
NCT ID: NCT01359644
Last Updated: 2015-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
350 participants
INTERVENTIONAL
2011-06-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Ribavirin
Tablets, oral, 200 mg
Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Ribavirin
Tablets, oral, 200 mg
Treatment G: PSI-7977 + Daclatasvir
Hepatitis C virus genotype 1, treatment-naive patients
Genotype 1a or 1b
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Treatment H: PSI-7977 + BMS-790052 + Ribavirin
Hepatitis C virus genotype 1, treatment-naive patients
Genotype 1a or 1b
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Ribavirin
Tablets, oral, 200 mg
Treatment I: PSI-7977 + Daclatasvir
Patients who experienced telaprevir/boceprevir treatment failure
Genotype 1a or 1b
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Treatment J: PSI-7977 + Daclatasvir + Ribavirin
Patients who experienced telaprevir/boceprevir treatment failure
Genotype 1a or 1b
PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Ribavirin
Tablets, oral, 200 mg
Interventions
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PSI-7977
Tablets, oral, 400 mg, once daily
Daclatasvir
Tablets, oral, 60 mg, once daily
Ribavirin
Tablets, oral, 200 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Pharmasset
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Southern California Liver Centers
Coronado, California, United States
Research And Education, Inc.
San Diego, California, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, United States
University Of Florida Hepatology
Gainesville, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Mercy Medical Center
Baltimore, Maryland, United States
Johns Hopkins University
Lutherville, Maryland, United States
University Of Michigan Health System
Ann Arbor, Michigan, United States
Weill Cornell Medical College
New York, New York, United States
Bronx Va Medical Center 3c Sub-J
The Bronx, New York, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Annandale, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
San Juan, , Puerto Rico
Countries
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References
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Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI444-040
Identifier Type: -
Identifier Source: org_study_id
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