This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.
Study Type
OBSERVATIONAL
Enrollment
42
Time to HCC recurrence - Prospective Cohort
Time to HCC recurrence associated with DAA therapy relative to no DAA therapy in the prospective cohort.
Time frame: up to 24 months
Number of events of early HCC recurrence - Prospective Cohort
Number of events (early HCC recurrence) associated with DAA therapy relative to no DAA therapy in the prospective cohort.
Time frame: up to 24 months
Time to HCC recurrence - Prospective Cohort relative to Historical Cohort
Time to HCC recurrence associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort.
Time frame: up to 24 months
Number of events of early HCC recurrence - Prospective Cohort relative to Historical Cohort
Number of events (early HCC recurrence) associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort. historical cohort of HCV patients not exposed to DAA with initial HCC diagnosis and subsequent successful treatment of HCC.
Time frame: up to 24 months
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Banner University Medical Center
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
California Liver Research Institute
Pasadena, California, United States
University of California - Davis Clinical Trials
Sacramento, California, United States
University of California - San Francisco
San Francisco, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Gastro Florida
Clearwater, Florida, United States
University of Florida Hepatology Research at CTRB
Gainesville, Florida, United States
...and 52 more locations