Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT01492504
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1850
Not provided
- Subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C (CHC) after completion of the previous study during which Asunaprevir and/or Daclatasvir were administered
- Subject must not be participating in any other trial, excluding non-interventional trials
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects with chronic hepatitis C Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C
- Primary Outcome Measures
Name Time Method Durability of Sustained viral response [SVR] (time to loss of virologic response) 24 or 48-week Intervals The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052). Loss of virologic response assessed using Hepatitis C virus (HCV) Ribonucleic acid (RNA)
- Secondary Outcome Measures
Name Time Method Frequency of viral genotypic substitutions in subjects previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) who did not achieve or did not maintain SVR12 24 or 48-week intervals Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality 24 or 48-week intervals
Trial Locations
- Locations (63)
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Peter J Ruane Md Inc
🇺🇸Los Angeles, California, United States
Anthony M. Mills Md Inc
🇺🇸Los Angeles, California, United States
Quest Clinical Research
🇺🇸San Diego, California, United States
Precision Research Institute, Llc
🇺🇸San Diego, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
U.Cal.-San Francisco
🇺🇸San Francisco, California, United States
University Of Colorado Denver & Hospital
🇺🇸Aurora, Colorado, United States
Schiff Center for Liver Diseases
🇺🇸Miami, Florida, United States
University Of Miami School Of Medicine
🇺🇸Miami, Florida, United States
Florida Hospital Transplant Center
🇺🇸Orlando, Florida, United States
Gastrointestinal Specialists Of Georgia
🇺🇸Marietta, Georgia, United States
Ruth M. Rothstein CORE Center
🇺🇸Chicago, Illinois, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Digestive Disease Associates, P.A.
🇺🇸Catonsville, Maryland, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
University Of Michigan
🇺🇸Ann Arbor, Michigan, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Southwest Care Center
🇺🇸Santa Fe, New Mexico, United States
University Of North Carolina At Chapel Hill School Of Med
🇺🇸Chapel Hill, North Carolina, United States
Nyu Medical Center
🇺🇸Great Neck, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Carolinas Center For Liver Disease
🇺🇸Statesville, North Carolina, United States
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Mayo Clinic Rochester
🇺🇸Tulsa, Oklahoma, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
University Of Pennsylvania School Of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Metropolitan Research
🇺🇸Annandale, Virginia, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Ssm Health Dean Med Group
🇺🇸Madison, Wisconsin, United States
Centro Oncologico Integral
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Instituto Centralizado De Asistencia E Investigacion Clinica
🇦🇷Prov De Santa Fe, Santa FE, Argentina
Hospital Austral
🇦🇷Prov. Buenos Aires, Buenos Aires, Argentina
Local Institution
🇬🇧London, Greater London, United Kingdom
Hospital Italiano De Buenos Aires
🇦🇷Buenos Aires, Argentina
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
St. James'S Hospital
🇮🇪Dublin 8, Dublin, Ireland
Mater Misericordiae University Hospital
🇮🇪Dublin 3, Dublin, Ireland
Pacific Oaks Medical Group
🇺🇸Beverly Hills, California, United States
Alabama Liver & Digestive Specialists (Alds)
🇺🇸Montgomery, Alabama, United States
Baylor College Of Medicine
🇺🇸Houston, Texas, United States
MEDVAMC
🇺🇸Houston, Texas, United States
Mcguire Dvamc
🇺🇸Richmond, Virginia, United States
Fundacion Cidea De Paraguay
🇦🇷Ciudad De Buenos Aires, Buenos Aires, Argentina
Imperial College London
🇬🇧London, Greater London, United Kingdom
Kings College Hospital
🇬🇧London, Greater London, United Kingdom
North Manchester General Hospital
🇬🇧Manchester, Greater Manchester, United Kingdom
Gartnaval General Hospital
🇬🇧Glasgow, United Kingdom
Keck Medical Center of USC, HCC 1
🇺🇸Los Angeles, California, United States
Southern California Research Center
🇺🇸Coronado, California, United States
Liver Associates Of Texas
🇺🇸Houston, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States