Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
NCT ID: NCT02639338
Last Updated: 2019-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2015-12-23
2017-01-02
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 FDC tablet administered orally once daily with food
SOF/VEL
SOF/VEL tablet for 12 weeks
SOF/VEL
400/100 mg FDC tablet administered orally once daily without regard to food
Interventions
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SOF/VEL/VOX
400/100/100 mg FDC tablet administered orally once daily with food
SOF/VEL
400/100 mg FDC tablet administered orally once daily without regard to 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 genotype 3 HCV infection (≥ 6 months)
* Presence of cirrhosis
* 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
Rialto, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Miami, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, 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
Hillsborough, New Jersey, United States
New York, New York, United States
The Bronx, New York, United States
Asheville, North Carolina, United States
Fayetteville, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Murray, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Camperdown, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Herston, Queensland, Australia
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
Melbourne, Victoria, Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Brampton, Ontario, Canada
Toronto, Ontario, Canada
Bobigny, , France
Clermont-Ferrand, , France
Clichy, , France
Créteil, , France
Limoges, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Nice, , France
Orléans, , France
Paris, , France
Pessac, , France
Rennes, , France
Strasbourg, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Bonn, , Germany
Cologne, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Hanover, , Germany
Grafton, Auckland, New Zealand
Christchurch, , 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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Foster GR, Thompson AJ, Ruane PJ, Borgia SM, Dore G, Workowski K, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study [Abstract 258]. J Hepatology 2016;63 (1S):135A
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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2015-002996-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-367-1173
Identifier Type: -
Identifier Source: org_study_id
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