Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT ID: NCT04211909
Last Updated: 2021-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
87 participants
INTERVENTIONAL
2020-01-03
2020-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOF/VEL
Participants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks.
SOF/VEL
400/100 mg FDC tablet orally once daily.
SOF/VEL/VOX
Participants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks.
SOF/VEL/VOX
400/100/100 mg FDC tablet orally once daily.
Interventions
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SOF/VEL
400/100 mg FDC tablet orally once daily.
SOF/VEL/VOX
400/100/100 mg FDC tablet orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment-naive or treatment-experienced individuals
* Non-cirrhosis or compensated cirrhosis at screening
19 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-D, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chosun University Hospital
Gwangju, , South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
VHS (Veterans Health Service) Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul Saint Mary's Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-342-5532
Identifier Type: -
Identifier Source: org_study_id