Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
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|ClinicalTrials.gov Identifier: NCT02951364|
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment|
|Hepatitis C Virus||Drug: LDV/SOF|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Harvoni Treatment Regimen in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea|
|Actual Study Start Date :||November 23, 2016|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Adult Korean participants and pediatric Korean participants aged 12 to <18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen
90/400 mg tablet administered orally once daily
- Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) [ Time Frame: Up to 30 days following treatment ]Incidence of adverse events (AEs) and special situation reports (SSRs) occurring during administration of Harvoni regimen or up to 30 days of treatments will be analyzed.
- Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]The sustained virologic response (SVR) rate will be assessed at 12 weeks after completion (or discontinuation) of Harvoni treatment, defined as the proportion of participants with HCV RNA < lower limit of quantification (LLOQ) from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24 (based on when the participant's actual visit occurs). The treatment will be assessed as "improved/success" when HCV RNA < LLOQ is achieved from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24.
- Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) [ Time Frame: Up to Posttreatment Week 12 ]Incidence of adverse events (AEs) and special situation reports (SSRs) occurring within 12 weeks after completion (or discontinuation) of treatments will be analyzed.
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): NCT02951364
|Contact: Gilead Study Team||GS-USemail@example.com|
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|Study Director:||Gilead Study Director||Gilead Sciences|