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
POLARIS-4
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
2 other identifiers
interventional
333
8 countries
78
Brief Summary
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2015
Shorter than P25 for phase_3
78 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
December 21, 2015
CompletedStudy Start
First participant enrolled
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
December 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2017
CompletedResults Posted
Study results publicly available
November 6, 2017
CompletedMarch 5, 2019
October 1, 2017
10 months
December 21, 2015
October 4, 2017
February 8, 2019
Conditions
Keywords
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) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
Up to 12 weeks
Secondary Outcomes (4)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ On Treatment
Weeks 1, 2, 4, 8 and 12
Change From Baseline in HCV RNA
Weeks 1, 2, 4, 8, and 12
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Study Arms (2)
SOF/VEL/VOX
EXPERIMENTALSOF/VEL/VOX for 12 weeks
SOF/VEL
EXPERIMENTALSOF/VEL for 12 weeks
Interventions
400/100/100 mg FDC tablet administered orally once daily with food
400/100 mg FDC tablet administered orally once daily without regard to food
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10\^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months)
- Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV
- Use of protocol specified methods of contraception
You may not qualify if:
- Current or prior history of clinically significant illness that may interfere with participation in the study
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Pregnant or nursing female
- Chronic liver disease not caused by HCV
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (78)
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Palo Alto, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
Rialto, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Englewood, Colorado, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Wellington, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Bastrop, Louisiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Catonsville, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Hillsborough, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Fayetteville, North Carolina, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Providence, Rhode Island, United States
Unknown Facility
Germantown, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Murray, Utah, United States
Unknown Facility
Falls Church, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Madison, Wisconsin, United States
Unknown Facility
Camperdown, New South Wales, Australia
Unknown Facility
Darlinghurst, New South Wales, Australia
Unknown Facility
Herston, Queensland, Australia
Unknown Facility
Clayton, Victoria, Australia
Unknown Facility
Melbourne, Victoria, Australia
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Brampton, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Clermont-Ferrand, France
Unknown Facility
Clichy, France
Unknown Facility
Grenoble, France
Unknown Facility
Lille, France
Unknown Facility
Limoges, France
Unknown Facility
Lyon, France
Unknown Facility
Marseille, France
Unknown Facility
Montpellier, France
Unknown Facility
Nice, France
Unknown Facility
Paris, France
Unknown Facility
Pessac, France
Unknown Facility
Toulouse, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Villejuif, France
Unknown Facility
Berlin, Germany
Unknown Facility
Bonn, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Frankfurt am Main, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Grafton, Auckland, New Zealand
Unknown Facility
San Juan, Puerto Rico
Unknown Facility
London, United Kingdom
Unknown Facility
Oxford, United Kingdom
Related Publications (1)
Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.
PMID: 28564569DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- 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
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2015
First Posted
December 24, 2015
Study Start
December 23, 2015
Primary Completion
October 5, 2016
Study Completion
January 18, 2017
Last Updated
March 5, 2019
Results First Posted
November 6, 2017
Record last verified: 2017-10
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.