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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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