Status:

COMPLETED

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Hepatitis C

Eligibility:

All Genders

18+ years

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 D...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • 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
  • Exclusion Criteria:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 7 2012

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 19 2018

    Estimated Enrollment :

    1850 Patients enrolled

    Trial Details

    Trial ID

    NCT01492504

    Start Date

    February 7 2012

    End Date

    March 19 2018

    Last Update

    November 27 2019

    Active Locations (161)

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    Page 1 of 41 (161 locations)

    1

    Alabama Liver & Digestive Specialists (Alds)

    Montgomery, Alabama, United States, 36116

    2

    Pacific Oaks Medical Group

    Beverly Hills, California, United States, 90211-2145

    3

    Southern California Research Center

    Coronado, California, United States, 92118

    4

    Scripps Clinic

    La Jolla, California, United States, 92037