An observational study in Hepatitis C, sponsored by University of North Carolina, Chapel Hill. Completed at 60 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by University of North Carolina, Chapel Hill · Observational
The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.
HCV-TARGET is a longitudinal, observational study that will create a carefully maintained research registry of HCV patients treated with antiviral therapies designed to rapidly inform strategies for better management of populations underrepresented in clinical trials, identify and remediate educational gaps relative to treatment guidelines and adverse event management in order to optimize rates of sustained virological response (SVR), and serve as the core resource for important collaborative translational studies utilizing biospecimens and clinical data from diverse patient populations.
HCV-TARGET is a cooperative academic consortium of principal investigators from Clinical and Translational Award (CTSA)-funded academic institutions and community-based sites affiliated with the academic sites in geographic proximity. The Clinical Coordinating Center (CCC) resides at the University of Florida and the Data Coordinating Center (DCC) resides at the University of North Carolina at Chapel Hill.
The HCV-TARGET registry will characterize the population of chronic hepatitis C (HCV) patients who are being treated with antiviral therapies at academic and community sites. Patient characteristics such as age, race, ethnicity, comorbidity, and disease and treatment status will be examined.
HCV-TARGET will also:
This study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis C, including the following:
The secondary aims for this study will investigate the following:
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 13,559 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and female adult patients: Aged 18 and older with chronic HCV treated with triple therapy (including protease inhibitors).
Exclusion Criteria:
Sustained virological response (SVR)
The primary outcome measure is the occurence (yes or no) of SVR, defined as undetectable HCV RNA in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various sub-populations enrolled in HCV-TARGET.
Time frame: 24 months
Treatment persistence
Treatment persistence will be the duration of treatment measured from the first dose of medication until treatment is discontinued. Reasons for premature discontinuation of treatment will be recorded.
Time frame: 24 months
Virological breakthrough
The occurrence of virological breakthrough defined as an increase of HCV RNA by at least 1-log over nadir or to \>100 IU if previously undetectable.
Time frame: 24 months
Management of adverse events
Specific interventions to manage selected adverse events, such as anemia and skin rash, will be tabulated and described
Time frame: 24 months
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill