Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) Versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) in Subjects With Chronic Hepatitis C Virus (HCV) Infection
Status: Recruiting
Location: See all (100) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Use of adequate contraception for females of childbearing potential
• Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)
• Documented medical history compatible with chronic HCV
• Either no liver cirrhosis or with compensated liver cirrhosis
• If HIV-1-positive, must meet the following 2 criteria:
‣ Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and plasma HIV-1 RNA \<LLOQ
⁃ Suitable ARV treatment and not taking any contraindicated medications
Locations
United States
Alabama
Atea Study Site
RECRUITING
Birmingham
Atea Study Site
RECRUITING
Dothan
Arkansas
Atea Study Site
RECRUITING
Little Rock
Arizona
Atea Study Site
RECRUITING
Chandler
Atea Study Site
RECRUITING
Flagstaff
Atea Study Site
RECRUITING
Mesa
Atea Study Site
RECRUITING
Phoenix
Atea Study Site
RECRUITING
Phoenix
Atea Study Site
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Tucson
California
Atea Study Site
RECRUITING
Bakersfield
Atea Study Site
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Coronado
Atea Study Site
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Escondido
Atea Study Site
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Fresno
Atea Study Site
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Long Beach
Atea Study Site
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Los Angeles
Atea Study Site
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Los Angeles
Atea Study Site
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Orange
Atea Study Site
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Pasadena
Atea Study Site
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Sacramento
Atea Study Site
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Torrance
Atea Study Site
RECRUITING
Valencia
Colorado
Atea Study Site
RECRUITING
Colorado Springs
Washington, D.c.
Atea Study Site
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Washington D.c.
Atea Study Site
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Washington D.c.
Florida
Atea Study Site
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Coral Gables
Atea Study Site
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Deland
Atea Study Site
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Fort Lauderdale
Atea Study Site
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Ft. Pierce
Atea Study Site
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Gainesville
Atea Study Site
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Inverness
Atea Study Site
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Jupiter
Atea Study Site
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Lauderdale Lakes
Atea Study Site
RECRUITING
Maitland
Atea Study Site
RECRUITING
Miami
Atea Study Site
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Miami Lakes
Atea Study Site
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Orlando
Atea Study Site
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Pembroke Pines
Atea Study Site
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Sarasota
Atea Study Site
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West Palm Beach
Georgia
Atea Study Site
RECRUITING
Macon
Atea Study Site
RECRUITING
Marietta
Illinois
Atea Study Site
RECRUITING
Chicago
Indiana
Atea Study Site
RECRUITING
New Albany
Kansas
Atea Study Site
RECRUITING
Fairway
Atea Study Site
RECRUITING
Topeka
Kentucky
Atea Study Site
RECRUITING
Louisville
Louisiana
Atea Study Site
RECRUITING
New Iberia
Atea Study Site
RECRUITING
New Orleans
Massachusetts
Atea Study Site
RECRUITING
Boston
Atea Study Site
RECRUITING
Springfield
Atea Study Site
RECRUITING
Worcester
Maryland
Atea Study Site
RECRUITING
Baltimore
Atea Study Site
RECRUITING
Baltimore
Michigan
Atea Study Site
RECRUITING
Grosse Pointe Woods
Atea Study Site
RECRUITING
Novi
Atea Study Site
RECRUITING
Wyoming
Mississippi
Atea Study Site
RECRUITING
Tupelo
North Carolina
Atea Study Site
RECRUITING
Asheville
Atea Study Site
RECRUITING
Charlotte
Atea Study Site
RECRUITING
Fayetteville
New Jersey
Atea Study Site
RECRUITING
Camden
Atea Study Site
RECRUITING
Hillsborough
Atea Study Site
RECRUITING
Newark
Atea Study Site
RECRUITING
Newark
New York
Atea Study Site
RECRUITING
Brooklyn
Atea Study Site
RECRUITING
New York
Atea Study Site
RECRUITING
Yonkers
Ohio
Atea Study Site
RECRUITING
Beavercreek
Atea Study Site
RECRUITING
Cincinnati
Oklahoma
Atea Study Site
RECRUITING
Tulsa
Pennsylvania
Atea Study Site
RECRUITING
Allentown
Atea Study Site
RECRUITING
Dubois
Atea Study Site
RECRUITING
Philadelphia
Atea Study Site
RECRUITING
Philadelphia
South Carolina
Atea Study Site
RECRUITING
Charleston
Tennessee
Atea Study Site
RECRUITING
Chattanooga
Atea Study Site
RECRUITING
Cordova
Atea Study Site
RECRUITING
Jackson
Texas
Atea Study Site
RECRUITING
Arlington
Atea Study Site
RECRUITING
Dallas
Atea Study Site
RECRUITING
Dallas
Atea Study Site
RECRUITING
Denison
Atea Study Site
RECRUITING
Houston
Atea Study Site
RECRUITING
Plano
Atea Study Site
RECRUITING
San Antonio
Atea Study Site
RECRUITING
Waco
Utah
Atea Study Site
RECRUITING
Ogden
Virginia
Atea Study Site
RECRUITING
Chesapeake
Atea Study Site
RECRUITING
Norfolk
Atea Study Site
RECRUITING
Richmond
Atea Study Site
RECRUITING
Richmond
Washington
Atea Study Site
RECRUITING
Seattle
Other Locations
Canada
Atea Study Site
RECRUITING
Moncton
Atea Study Site
RECRUITING
Montreal
Atea Study Site
RECRUITING
Ottawa
Atea Study Site
RECRUITING
Québec
Atea Study Site
RECRUITING
Québec
Atea Study Site
RECRUITING
St. John's
Atea Study Site
RECRUITING
Toronto
Atea Study Site
RECRUITING
Vancouver
Contact Information
Primary
Clinical Trials Administrator
ateaclinicaltrials@ateapharma.com
1-(857) 284-8891
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 880
Treatments
Experimental: Bemnifosbuvir-Ruzasvir (BEM/RZR)
Active_comparator: Sofosbuvir-Velpatasvir (SOF/VEL)
Related Therapeutic Areas
Sponsors
Leads: Atea Pharmaceuticals, Inc.