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

• Status: Completed
• Trial end date: 2018-03-19
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir

Criteria

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