An observational study in Hepatitis C, sponsored by Gilead Sciences. Completed at 125 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-06.
Sponsored by Gilead Sciences · Observational
This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 3,294 is above the median of 245 across 574 observational studies indexed under Hepatitis C.
Browse Hepatitis C studies →Gilead Sciences is the lead sponsor of 689 studies on the registry; 24 are open to participants now.
Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.
Drug: Harvoni
Harvoni (90/400 mg) FDC tablet administered orally once daily
Also known as: LDV/SOF, GS-5885/GS-7977
Incidence of adverse drug reaction (ADR) under real world settings
Time frame: Up to 16 weeks
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
SVR12 and SVR24 are defined as HCV RNA \< the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.
Time frame: Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
Time frame: Approximately 12 weeks after treatment completion or discontinuation
Showing the first 100 of 125 sites.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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