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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)

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ClinicalTrials.gov Identifier: NCT02639247
Recruitment Status : Completed
First Posted : December 24, 2015
Results First Posted : November 6, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL/VOX Drug: SOF/VEL Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 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
Actual Study Start Date : December 23, 2015
Actual Primary Completion Date : October 5, 2016
Actual Study Completion Date : January 18, 2017

Arm Intervention/treatment
Experimental: SOF/VEL/VOX
SOF/VEL/VOX for 12 weeks
Drug: SOF/VEL/VOX
400/100/100 mg FDC tablet administered orally once daily with food
Other Names:
  • Vosevi®
  • GS-7977/GS-5816/GS-9857

Experimental: SOF/VEL
SOF/VEL for 12 weeks
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily without regard to food
Other Names:
  • Epclusa®
  • GS-7977/GS-5816




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage 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 SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Weeks 1, 2, 4, 8 and 12 ]
  3. Change From Baseline in HCV RNA [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
  4. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
    • On-treatment virologic failure:

      • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
      • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
      • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
    • Virologic relapse:

      • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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

Key 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 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)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639247


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Locations
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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
Wellington, 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
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
Nashville, Tennessee, United States
United States, Texas
Houston, 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
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
Melbourne, Victoria, 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
France
Clermont-Ferrand, France
Clichy, France
Grenoble, France
Lille, France
Limoges, France
Lyon, France
Marseille, France
Montpellier, France
Nice, France
Paris, France
Pessac, 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
Grafton, Auckland, New Zealand
Puerto Rico
San Juan, Puerto Rico
United Kingdom
London, United Kingdom
Oxford, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02639247     History of Changes
Other Study ID Numbers: GS-US-367-1170
2015-003167-10 ( EudraCT Number )
First Posted: December 24, 2015    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: March 5, 2019
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/about/ethics-and-code-of-conduct/policies

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Chronic

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis C
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Velpatasvir
Sofosbuvir
Antiviral Agents
Anti-Infective Agents