An observational study in Hepatitis C, Chronic, sponsored by Gilead Sciences. Completed at 325 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by Gilead Sciences · Observational
This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 6,625 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored HCV study.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Proportion of participants maintaining SVR at Week 144 by treatment regimen
Time frame: Week 144
Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen
Time frame: Up to 144 weeks
Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen
Time frame: Up to 144 weeks
Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen
Time frame: Up to 144 weeks
Liver disease progression
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.
Time frame: Up to 144 weeks
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen
Time frame: Up to 144 weeks
Showing the first 100 of 325 sites across 17 countries.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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