Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NCT ID: NCT03118843
Last Updated: 2019-04-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2017-04-25
2018-03-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
NCT02639338
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
NCT02607735
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
NCT02639247
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
NCT02536313
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
NCT02607800
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SOF/VEL/VOX
SOF/VEL/VOX for 12 weeks
SOF/VEL/VOX
400/100/100 mg FDC tablet administered orally once daily with food
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SOF/VEL/VOX
400/100/100 mg FDC tablet administered orally once daily with food
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ruane Clinical Research Group Inc.
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Stanford Hospital and Clinics
Palo Alto, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Kaiser Permanente
San Diego, California, United States
University of Colorado Denver (Leprino Building)
Aurora, Colorado, United States
Orlando Immunology Center
Orlando, Florida, United States
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit
St Louis, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center/ New York Presbyterian
New York, New York, United States
Center for Liver Diseases, Oakland
Pittsburgh, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
University of Washington/Harborview Medical Center
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Translational Research Centre
Darlinghurst, New South Wales, Australia
Kay Edmonton Clinic
Edmonton, , Canada
Toronto Centre for Liver Disease (TCLD), Toronto General Hospital
Toronto, , Canada
Centre Hospitalier Universitaire de Rouen
Rouen, , France
Leber- and Studienzentrum am Checkpoint
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Auckland Clinical Studies Ltd
Grafton, Auckland, New Zealand
Christchurch Clinical Studies Trust, Ltd
Christchurch, , New Zealand
Kings College Hospital NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ruane P, Strasser SJ, Gane EJ, Hyland RH, Shao J, Dvory-Sobol H, et al. Retreatment with Sofosbuvir/Velpatasvir/Voxilaprevir for 12 weeks is safe and effective for patients who have previously received Sofosbuvir/Velpatasvir or Sofosbuvir/Velpatasvir/Voxilaprevir [Abstract LBO-06]. 16th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD); 2018 14-17 June; Toronto, Canada
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-000179-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-367-4181
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.