This trial is active, not recruiting.

Condition hepatitis c
Treatment asunaprevir (bms-650032) and/or daclatasvir (bms-790052)
Sponsor Bristol-Myers Squibb
Start date February 2012
End date February 2021
Trial size 1850 participants
Trial identifier NCT01492504, 2011-005287-21, AI444-046


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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
asunaprevir (bms-650032) and/or daclatasvir (bms-790052)
Observational study - No Intervention [(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)]

Primary Outcomes

Durability of Sustained viral response [SVR] (time to loss of virologic response)
time frame: 24 or 48-week Intervals

Secondary Outcomes

Frequency of viral genotypic substitutions in subjects previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) who did not achieve or did not maintain SVR12
time frame: 24 or 48-week intervals
Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality
time frame: 24 or 48-week intervals

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.