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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

A Long-Term Follow-up Study of 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

Keywords

Hepatitis C

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • Anthony M. Mills Md Inc
    Los Angeles, California, 90069, United States
  • Pacific Oaks Medical Group
    Beverly Hills, California, 90211-2145, United States
  • Peter J Ruane Md Inc
    Los Angeles, California, 90036, United States
  • Local Institution
    Los Angeles, California, 90033, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Investigator Inquiry Form
ID
NCT01492504
Study Type
Observational
Last Updated
August 1, 2017