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A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects with Chronic HCV Infection who Have Not Received an NS5A Inhibitor (POLARIS 4: GS-US-367-1170)
A study for patients with Chronic HCV Infection who have not received an NS5A Inhibitor using study drugs Sofosbuvir/Velpatasvir/GS-9857
| Sponsor: | Gilead Sciences, Inc |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAQ4901 |
| U.S. Govt. ID: | NCT00000000 |
| Contact: | Theresa Lukose: 212-305-6758 / tt2103@cumc.columbia.edu |
Additional Study Information:
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL FDC) for 12 weeks for the treatment of chronic hepatitis C virus (HCV) infection in subjects who have previously been unsuccessfully treated for chronic HCV.. An experimental drug is one that is currently being tested and has not been approved by the Food and Drug Administration (FDA) for use in the United States. Experimental drugs may be tested in research studies such as this one. You are being asked to participate in this study because you have chronic HCV infection, and were unsuccessfully treated in the past.
This study is closed
