Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
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|ClinicalTrials.gov Identifier: NCT02592057|
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment|
|Hepatitis C Virus||Drug: SOF|
|Study Type :||Observational|
|Actual Enrollment :||532 participants|
|Official Title:||A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India|
|Actual Study Start Date :||November 30, 2015|
|Actual Primary Completion Date :||November 30, 2017|
|Actual Study Completion Date :||April 23, 2018|
Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information.
SOF tablets administered orally once daily based on approved prescribing information
- Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen [ Time Frame: Up to Posttreatment Week 4 ]
- Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ) 12 weeks following the last dose of study drug, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592057
|Study Director:||Gilead Study Director||Gilead Sciences|