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
NCT ID: NCT02607800
Last Updated: 2019-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
943 participants
INTERVENTIONAL
2015-11-16
2017-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOF/VEL/VOX
SOF/VEL/VOX tablet for 8 weeks
SOF/VEL/VOX
400/100/100 mg tablet administered orally once daily with food
SOF/VEL 12 weeks
SOF/VEL tablet for 12 weeks
SOF/VEL
400/100 mg tablet administered orally once daily with or without food
Interventions
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SOF/VEL/VOX
400/100/100 mg tablet administered orally once daily with food
SOF/VEL
400/100 mg tablet administered orally once daily with or without food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Aurora, Colorado, United States
Englewood, Colorado, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Bastrop, Louisiana, United States
Baltimore, Maryland, United States
Catonsville, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Hillsborough, New Jersey, United States
Manhasset, New York, United States
New York, New York, United States
The Bronx, New York, United States
Asheville, North Carolina, United States
Fayetteville, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Live Oak, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Darlinghurst, New South Wales, Australia
Herston, Queensland, Australia
Fitzroy, Victoria, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Brampton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Bobigny, , France
Clermont-Ferrand, , France
Clichy, , France
Créteil, , 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
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Berlin, , Germany
Bonn, , Germany
Cologne, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Hanover, , Germany
Christchurch, , New Zealand
Grafton, , New Zealand
San Juan, , Puerto Rico
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Oxford, , United Kingdom
Portsmouth, , United Kingdom
Countries
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References
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Jacobson IM, Asselah T, Nahass R, Bhandari BR, Tran A, Hyland RH, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study [Abstract LB-12]. Hepatology AASLD Abstracts 2016;64 (6 (suppl)):1126A.
Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Brau N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 5.
Other Identifiers
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2015-003460-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-367-1172
Identifier Type: -
Identifier Source: org_study_id
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