Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
NCT ID: NCT01455090
Last Updated: 2017-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
320 participants
INTERVENTIONAL
2011-11-30
2015-07-31
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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Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks
BMS-790052 60 mg tablet by mouth once daily for 24 Weeks
BMS 791325 75 mg table by mouth twice daily for 24 Weeks
BMS-650032
BMS-790052
BMS-791325
Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 60 mg tablet by mouth once daily for 12 Weeks
BMS 791325 75 mg table by mouth twice daily for 12 Weeks
BMS-650032
BMS-790052
BMS-791325
Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)
\* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks
BMS-790052 60 mg tablet by mouth once daily for 24 Weeks
BMS 791325 150 mg table by mouth twice daily for 24 Weeks
BMS-650032
BMS-790052
BMS-791325
Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)
\* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 60 mg tablet by mouth once daily for 12 Weeks
BMS 791325 150 mg table by mouth twice daily for 12 Weeks
BMS-650032
BMS-790052
BMS-791325
Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
\* Genotype 1 treatment-naive subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 75 mg table by mouth twice daily for 12 Weeks
BMS-650032
BMS-790052
BMS-791325
Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
\* Genotype 1 treatment-naive subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 150 mg table by mouth twice daily for 12 Weeks
BMS-650032
BMS-790052
BMS-791325
Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
\* Genotype 4 treatment-naive subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 75 mg table by mouth twice daily for 12 Weeks
BMS-650032
BMS-790052
BMS-791325
Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
\* Genotype 4 treatment-naive subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 150 mg table by mouth twice daily for 12 Weeks
BMS-650032
BMS-790052
BMS-791325
Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
\* Genotype 1 treatment-null/non-responder subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 75 mg table by mouth twice daily for 12 Weeks
BMS-650032
BMS-790052
BMS-791325
Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
\* Genotype 1 treatment-null/non-responder subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 150 mg table by mouth twice daily for 12 Weeks
BMS-650032
BMS-790052
BMS-791325
Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
\* Genotype 1 treatment-null/non-responder subjects
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks
BMS 791325 75 mg table by mouth twice daily for 24 Weeks
BMS-650032
BMS-790052
BMS-791325
Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
\* Genotype 1 treatment-null/non-responder subjects
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks
BMS 791325 150 mg table by mouth twice daily for 24 Weeks
BMS-650032
BMS-790052
BMS-791325
Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBV
\* Genotype 1 treatment-naive subjects
BMS-650032 200 mg tablets orally twice daily 12 weeks
BMS-790052 30 mg tablets orally twice daily 12 weeks
BMS-791325 75 mg tablets orally twice daily 12 weeks
Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks \[if subject is \< 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM\]
BMS-650032
BMS-790052
BMS-791325
Ribavirin
Interventions
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BMS-650032
BMS-790052
BMS-791325
Ribavirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment
* Subjects should have chronic hepatitis C (CHC) as documented by:
1. 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 the time of screening, or
2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)
* HCV genotype 1a, 1b or 4 only
* HCV RNA viral load of ≥10,000 IU/mL at screening
* Have one of the following:
1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis
* Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
* Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening
Exclusion Criteria
* History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
* 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
* Documented or suspected hepatocellular carcinoma (HCC)
* Positive for hepatitis B surface antigen (HBsAg)
* Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies
* Alanine transferase (transminase) (ALT) \>5x upper limit of normal (ULN)
* Total Bilirubin ≥2 mg/dL
18 Years
ALL
No
Sponsors
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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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The Kirklin Clinic
Birmingham, Alabama, United States
Southern California Research Center
Coronado, California, United States
Peter J Ruane Md Inc
Los Angeles, California, United States
Va Greater Los Angeles Healthcare System
Los Angeles, California, United States
Research And Education, Inc.
San Diego, California, United States
Precision Research Institute, Llc
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
University Of Colorado Denver And Hospital
Aurora, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Orlando Immunology Center
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Atlanta Gastroenterology Associates, Llc
Atlanta, Georgia, United States
Mercy Medical Center, Inc.
Baltimore, Maryland, United States
Johns Hopkins University
Lutherville, Maryland, United States
Id Care
Hillsborough, New Jersey, United States
Southwest Care Center
Santa Fe, New Mexico, United States
James J Peters Vamc
The Bronx, New York, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Research Specialists Of Texas
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Metropolitan Research
Fairfax, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
Clichy, , France
Local Institution
Créteil, , France
Local Institution
Limoges, , France
Local Institution
Marseille, , France
Local Institution
Paris, , France
Fundacion De Investigacion De Diego
San Juan, , Puerto Rico
Countries
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References
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Everson GT, Sims KD, Thuluvath PJ, Lawitz E, Hassanein T, Rodriguez-Torres M, Desta T, Hawkins T, Levin JM, Hinestrosa F, Rustgi V, Schwartz H, Younossi Z, Webster L, Gitlin N, Eley T, Huang SP, McPhee F, Grasela DM, Gardiner DF. Daclatasvir + asunaprevir + beclabuvir +/- ribavirin for chronic HCV genotype 1-infected treatment-naive patients. Liver Int. 2016 Feb;36(2):189-97. doi: 10.1111/liv.12964. Epub 2015 Dec 6.
Everson GT, Sims KD, Rodriguez-Torres M, Hezode C, Lawitz E, Bourliere M, Loustaud-Ratti V, Rustgi V, Schwartz H, Tatum H, Marcellin P, Pol S, Thuluvath PJ, Eley T, Wang X, Huang SP, McPhee F, Wind-Rotolo M, Chung E, Pasquinelli C, Grasela DM, Gardiner DF. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology. 2014 Feb;146(2):420-9. doi: 10.1053/j.gastro.2013.10.057. Epub 2013 Oct 30.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-002788-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI443-014
Identifier Type: -
Identifier Source: org_study_id
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