Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
NCT ID: NCT01012895
Last Updated: 2015-10-09
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
215 participants
INTERVENTIONAL
2009-12-31
2014-02-28
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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Arm 1: Sentinel A
BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Arm 2: Sentinel B
BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Ribavirin
Tablets, Oral
For subjects weighing \< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg
Twice daily (\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks
Arm 3: Expansion A1
BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Arm 4: Expansion A2
BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Arm 5: Expansion B1
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Ribavirin
Tablets, Oral
For subjects weighing \< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg
Twice daily (\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks
Arm 6: Expansion B2
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Ribavirin
Tablets, Oral
For subjects weighing \< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg
Twice daily (\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks
Arm 7: Expansion B3
BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Ribavirin
Tablets, Oral
For subjects weighing \< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg
Twice daily (\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks
Interventions
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BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Ribavirin
Tablets, Oral
For subjects weighing \< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg
Twice daily (\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV-Infected Genotype 1 Null responders to current standard of care
* Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.
Exclusion Criteria
* History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
* History of Cancer within 5 years of enrollment
* History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
* History of clinically significant cardiac disease
* History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Documented cirrhosis within 12 months prior to dosing
* Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
* Pregnant
18 Years
70 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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Advanced Clinical Research Institute
Anaheim, California, United States
Southern California Liver Centers
Coronado, California, United States
San Jose Gastroenterology
San Jose, California, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, United States
Mercy Medical Center
Baltimore, Maryland, United States
University Of Michigan Health System
Ann Arbor, Michigan, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, United States
Texas Clinical Research Institute, Llc
Arlington, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Local Institution
Clichy, , France
Local Institution
Créteil, , France
Local Institution
Marseille, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Pessac, , France
Local Institution
San Juan, , Puerto Rico
Countries
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References
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Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.
McPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16.
Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2010-024637-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI447-011
Identifier Type: -
Identifier Source: org_study_id
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