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

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)

• Registration Number: NCT01492504
• Lead Sponsor: Bristol-Myers Squibb

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 Daclatasvir (BMS-790052) and achieved sustained virologic response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Study Start: 2012-02-07
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1850

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with chronic hepatitis C	Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)	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

Primary Outcome Measures

Name	Time	Method
Durability of Sustained viral response [SVR] (time to loss of virologic response)	24 or 48-week Intervals	The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052). Loss of virologic response assessed using Hepatitis C virus (HCV) Ribonucleic acid (RNA)

Secondary Outcome Measures

Name	Time	Method
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	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	24 or 48-week intervals

Trial Locations

Locations (63)

Alabama Liver & Digestive Specialists (Alds); 🇺🇸 Montgomery, Alabama, United States

Pacific Oaks Medical Group; 🇺🇸 Beverly Hills, California, United States

Southern California Research Center; 🇺🇸 Coronado, California, United States

Scripps Clinic; 🇺🇸 La Jolla, California, United States

Keck Medical Center of USC, HCC 1; 🇺🇸 Los Angeles, California, United States

Peter J Ruane Md Inc; 🇺🇸 Los Angeles, California, United States

Anthony M. Mills Md Inc; 🇺🇸 Los Angeles, California, United States

Precision Research Institute, Llc; 🇺🇸 San Diego, California, United States

Quest Clinical Research; 🇺🇸 San Diego, California, United States

Medical Associates Research Group; 🇺🇸 San Diego, California, United States

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