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

Completed

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01492504

Run by

Bristol-Myers Squibb

People needed

1850

Starts

2012-02-07

Expected to finish

2018-03-19

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Written Informed Consent
• Subjects must have received at least one dose of Asunaprevir and/or Daclatasvir
• Subjects participating in Daclatasvir and/or Asunaprevir studies (ie, protocol numbers beginning with AI443, AI444 or AI447) may enroll regardless of virologic response
• Completed the required post-treatment follow-up period in previous study
• Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
• Men and women, ages 18 and older

You may not qualify if…

• 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

Where it is running

• Pacific Oaks Medical Group — Beverly Hills, California, United States
• Southern California Research Center — Coronado, California, United States
• Scripps Clinic — La Jolla, California, United States
• Keck Medical Center of USC, HCC 1 — Los Angeles, California, United States
• Peter J Ruane Md Inc — Los Angeles, California, United States
• Anthony M. Mills Md Inc — Los Angeles, California, United States
• Precision Research Institute, Llc — San Diego, California, United States
• Quest Clinical Research — 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
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Schiff Center for Liver Diseases — Miami, Florida, United States
• University Of Miami School Of Medicine — Miami, Florida, United States
• Orlando Immunology Center — Orlando, 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
• Indiana University — Indianapolis, Indiana, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Digestive Disease Associates, P.A. — Catonsville, Maryland, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• The Research Institute — Springfield, Massachusetts, United States
• University Of Michigan — Ann Arbor, Michigan, United States
• Alabama Liver & Digestive Specialists (Alds) — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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