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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)

Study type: Observational

Funder types: Industry

Identifiers

NCT01492504

2011-005287-21 (EudraCT Number)

AI444-046

Details and patient eligibility

About

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.

Enrollment: 1,850 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,850 participants in 1 patient group

Subjects with chronic hepatitis C

Description:

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

Treatment:

Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)