A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01457768
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 570
- Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV
- Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol
- Provide written, informed consent
- Be willing and able to comply with the visit schedule
Key
- Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry
- History of clinically significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen Up to 3 years
- Secondary Outcome Measures
Name Time Method Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen Up to 3 years Average number of DRM loss by treatment regimen Up to 3 years Liver disease progression Up to 3 years Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen Up to 144 weeks
Related Research Topics
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Trial Locations
- Locations (310)
Birmingham Gastroenterology Associates
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Digestive Health Specialists
🇺🇸Tupelo, Mississippi, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Advanced Clinical Research Institute, LLC
🇺🇸Anaheim, California, United States
Franco Felizarta, MD
🇺🇸Bakersfield, California, United States
Southern California Medical Group
🇺🇸Coronado, California, United States
West Coast Clinical Trials, LLC
🇺🇸Costa Mesa, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Scroll for more (300 remaining)Birmingham Gastroenterology Associates🇺🇸Birmingham, Alabama, United States