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History of Changes for Study: NCT02607800
Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-2)
Latest version (submitted February 8, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 16, 2015 None (earliest Version on record)
2 December 8, 2015 Recruitment Status, Study Status and Contacts/Locations
3 January 18, 2016 Contacts/Locations and Study Status
4 February 29, 2016 Contacts/Locations and Study Status
5 April 5, 2016 Study Status and Contacts/Locations
6 May 15, 2016 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Study Design, Study Description and Study Identification
7 October 26, 2016 Study Status, Contacts/Locations and Eligibility
8 January 16, 2017 Recruitment Status, Study Status and Contacts/Locations
9 October 10, 2017 Study Status, Outcome Measures, References, Contacts/Locations, Arms and Interventions, Oversight, Results and Study Description
10 February 8, 2019 IPDSharing, Contacts/Locations and Study Status
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Study NCT02607800
Submitted Date:  November 16, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: GS-US-367-1172
Brief Title: Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-2)
Official Title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection
Secondary IDs: 2015-003460-36 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 2015
Overall Status: Not yet recruiting
Study Start: November 2015
Primary Completion: January 2017 [Anticipated]
Study Completion: March 2017 [Anticipated]
First Submitted: November 16, 2015
First Submitted that
Met QC Criteria:
November 16, 2015
First Posted: November 18, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 16, 2015
Last Update Posted: November 18, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Gilead Sciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study will evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/GS-9857 (SOF/VEL/GS-9857) and SOF/VEL in adults with chronic HCV infection who have not previously received treatment with direct-acting antiviral therapy.
Detailed Description:
Open or close this module Conditions
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Infection
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 780 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SOF/VEL/GS-9857
SOF/VEL/GS-9857 tablet for 8 weeks
Drug: SOF/VEL/GS-9857
SOF/VEL/GS-9857 tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816/GS-9857
Active Comparator: SOF/VEL 12 weeks
SOF/VEL tablet for 12 weeks
Drug: SOF/VEL
SOF/VEL tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
[ Time Frame: Posttreatment Week 12 ]

SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
2. Proportion of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
[ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures:
1. Proportion of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
[ Time Frame: Posttreatment Weeks 4 and 24 ]

SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
2. Proportion of Participants With HCV RNA < LLOQ On Treatment
[ Time Frame: Up to 12 weeks ]

3. Change From Baseline in HCV RNA
[ Time Frame: Up to 12 weeks ]

4. Proportion of Participants With Virologic Failure
[ Time Frame: Up to Posttreatment Week 24 ]

Virologic failure is defined as:

  • On-treatment virologic failure:
    • Confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, or
    • Confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or
    • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
  • Viral relapse
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL at screening
  • Chronic HCV infection (≥ 6 months)
  • HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
  • Use of protocol specified methods of contraception

Exclusion Criteria:

  • Current or prior history of clinically significant illness that may interfere with participation in the study
  • Screening ECG with clinically significant abnormalities
  • Laboratory parameters outside the acceptable range at screening
  • Pregnant or nursing female
  • Chronic liver disease not caused by HCV
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Open or close this module Contacts/Locations
Central Contact Person: Gilead Study Team
Email: POLARISalerts@gilead.com
Study Officials: Robert H. Hyland, DPhil
Study Director
Gilead Sciences
Locations: United States, California
Long Beach, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Pasadena, California, United States
Rialto, California, United States
San Diego, California, United States
San Francisco, California, United States
United States, Colorado
Aurora, Colorado, United States
Englewood, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Gainesville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Marietta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Louisiana
Bastrop, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
Catonsville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
United States, Missouri
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
United States, New Jersey
Hillsborough, New Jersey, United States
United States, New York
Bronx, New York, United States
Manhasset, New York, United States
New York, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Fayetteville, North Carolina, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Tennessee
Germantown, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
Live Oak, Texas, United States
San Antonio, Texas, United States
United States, Utah
Murray, Utah, United States
United States, Virginia
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Richmnond, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Australia, New South Wales
Camperdown, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Australia, Queensland
Herston, Queensland, Australia
Australia, Victoria
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
Melbourne, Victoria, Australia
Australia, Western Australia
Perth, Western Australia, Australia
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Brampton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
France
Bobigny, France
Clermont-Ferrand, France
Clichy, France
Creteil, France
Grenoble, France
Lille, France
Limoges, France
Lyon, France
Marseille, France
Montpellier, France
Nice, France
Orléans, France
Paris, France
Pessac, France
Rennes, France
Rouen, France
Strasbourg, France
Toulouse, France
Vandoeuvre-les-Nancy, France
Villejuif, France
Germany
Berlin, Germany
Bonn, Germany
Frankfurt am Main, Germany
Hamburg, Germany
Hannover, Germany
Köln, Germany
New Zealand
Christchurch, New Zealand
Grafton, New Zealand
Puerto Rico
San Juan, Puerto Rico
United Kingdom
London, United Kingdom
Manchester, United Kingdom
Nottingham, United Kingdom
Oxford, United Kingdom
Portsmouth, United Kingdom
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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