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
An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
2 other identifiers
interventional
31
7 countries
27
Brief Summary
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2017
Shorter than P25 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
April 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2018
CompletedResults Posted
Study results publicly available
April 3, 2019
CompletedApril 3, 2019
March 1, 2019
11 months
April 13, 2017
March 8, 2019
March 8, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to Week 12
Secondary Outcomes (4)
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ On Treatment
Weeks 2, 4, 8, and 12
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 12
Change From Baseline in HCV RNA
Baseline; Weeks 2, 4, 8, and 12
Study Arms (1)
SOF/VEL/VOX
EXPERIMENTALSOF/VEL/VOX for 12 weeks
Interventions
400/100/100 mg FDC tablet administered orally once daily with food
Eligibility Criteria
You may qualify if:
- Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (27)
Ruane Clinical Research Group Inc.
Los Angeles, California, 90036, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford Hospital and Clinics
Palo Alto, California, 94304, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Kaiser Permanente
San Diego, California, 92154, United States
University of Colorado Denver (Leprino Building)
Aurora, Colorado, 80045, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit
St Louis, Missouri, 63104, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Columbia University Medical Center/ New York Presbyterian
New York, New York, 10032, United States
Center for Liver Diseases, Oakland
Pittsburgh, Pennsylvania, 15213, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Gastro One
Germantown, Tennessee, 38138, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
University of Washington/Harborview Medical Center
Seattle, Washington, 98104, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Translational Research Centre
Darlinghurst, New South Wales, 2010, Australia
Kay Edmonton Clinic
Edmonton, T6G IZI, Canada
Toronto Centre for Liver Disease (TCLD), Toronto General Hospital
Toronto, M5G 2C4, Canada
Centre Hospitalier Universitaire de Rouen
Rouen, 76031, France
Leber- and Studienzentrum am Checkpoint
Berlin, 10969, Germany
Universitatsklinikum Bonn
Bonn, 53127, Germany
Auckland Clinical Studies Ltd
Grafton, Auckland, 1010, New Zealand
Christchurch Clinical Studies Trust, Ltd
Christchurch, 8011, New Zealand
Kings College Hospital NHS Trust
London, SE5 9RS, United Kingdom
Related Publications (1)
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
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 18, 2017
Study Start
April 25, 2017
Primary Completion
March 19, 2018
Study Completion
March 19, 2018
Last Updated
April 3, 2019
Results First Posted
April 3, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.