ACTIVE_NOT_RECRUITING

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

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Conditions

HEPATITIS C VIRUS CHRONIC INFECTION

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

Official Title

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

Quick Facts

Study Start:2025-04-07
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06868264

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Use of adequate contraception for females of childbearing potential
  2. * Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)
  3. * Documented medical history compatible with chronic HCV
  4. * Either no liver cirrhosis or with compensated liver cirrhosis
  5. * If HIV-1-positive, must meet the following 2 criteria:
  6. 1. Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and plasma HIV-1 RNA \<LLOQ
  7. 2. Suitable ARV treatment and not taking any contraindicated medications
  1. * Pregnant or breastfeeding
  2. * Co-infected with hepatitis B virus
  3. * Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
  4. * Requirement of any prohibited medications
  5. * Use of other investigational drugs within 30 days of dosing
  6. * History or signs of decompensated liver disease (decompensated cirrhosis)
  7. * History of hepatocellular carcinoma (HCC)
  8. * Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results

Contacts and Locations

Study Locations (Sites)

Atea Study Site
Birmingham, Alabama, 35215
United States
Atea Study Site
Dothan, Alabama, 36301
United States
Atea Study Site
Chandler, Arizona, 85225
United States
Atea Study Site
Flagstaff, Arizona, 86001
United States
Atea Study Site
Mesa, Arizona, 85210
United States
Atea Study Site
Phoenix, Arizona, 85006
United States
Atea Study Site
Phoenix, Arizona, 85015
United States
Atea Study Site
Tucson, Arizona, 85745
United States
Atea Study Site
Little Rock, Arkansas, 72204
United States
Atea Study Site
Bakersfield, California, 93301
United States
Atea Study Site
Coronado, California, 92118
United States
Atea Study Site
Escondido, California, 92025
United States
Atea Study Site
Fresno, California, 93711
United States
Atea Study Site
Long Beach, California, 98015
United States
Atea Study Site
Los Angeles, California, 90048
United States
Atea Study Site
Los Angeles, California, 90067
United States
Atea Study Site
Orange, California, 92868
United States
Atea Study Site
Pasadena, California, 91105
United States
Atea Study Site
Sacramento, California, 95817
United States
Atea Study Site
Torrance, California, 90502
United States
Atea Study Site
Valencia, California, 91355
United States
Atea Study Site
Colorado Springs, Colorado, 80907
United States
Atea Study Site
Washington D.C., District of Columbia, 20017
United States
Atea Study Site
Washington D.C., District of Columbia, 20037
United States
Atea Study Site
Coral Gables, Florida, 33134
United States
Atea Study Site
DeLand, Florida, 32720
United States
Atea Study Site
Fort Lauderdale, Florida, 33308
United States
Atea Study Site
Ft. Pierce, Florida, 34982
United States
Atea Study Site
Gainesville, Florida, 32610
United States
Atea Study Site
Inverness, Florida, 34452
United States
Atea Study Site
Jupiter, Florida, 33458
United States
Atea Study Site
Lauderdale Lakes, Florida, 33313
United States
Atea Study Site
Maitland, Florida, 32751
United States
Atea Study Site
Miami, Florida, 33125
United States
Atea Study Site
Miami Lakes, Florida, 33014
United States
Atea Study Site
Orlando, Florida, 32803
United States
Atea Study Site
Pembroke Pines, Florida, 33024
United States
Atea Study Site
Sarasota, Florida, 34237
United States
Atea Study Site
West Palm Beach, Florida, 33407
United States
Atea Study Site
Macon, Georgia, 31201
United States
Atea Study Site
Marietta, Georgia, 30060
United States
Atea Study Site
Chicago, Illinois, 60613
United States
Atea Study Site
New Albany, Indiana, 47150
United States
Atea Study Site
Fairway, Kansas, 66205
United States
Atea Study Site
Topeka, Kansas, 66606
United States
Atea Study Site
Louisville, Kentucky, 40218
United States
Atea Study Site
New Iberia, Louisiana, 70560
United States
Atea Study Site
New Orleans, Louisiana, 70112
United States
Atea Study Site
Baltimore, Maryland, 21201
United States
Atea Study Site
Baltimore, Maryland, 21287
United States
Atea Study Site
Boston, Massachusetts, 02114
United States
Atea Study Site
Boston, Massachusetts, 02118
United States
Atea Study Site
Springfield, Massachusetts, 01105
United States
Atea Study Site
Worcester, Massachusetts, 01655
United States
Atea Study Site
Detroit, Michigan, 48201
United States
Atea Study Site
Grosse Pointe Woods, Michigan, 48236
United States
Atea Study Site
Novi, Michigan, 48377
United States
Atea Study Site
Wyoming, Michigan, 49519
United States
Atea Study Site
Tupelo, Mississippi, 38801
United States
Atea Study Site
Camden, New Jersey, 08103
United States
Atea Study Site
Hackensack, New Jersey, 07601
United States
Atea Study Site
Hillsborough, New Jersey, 08844
United States
Atea Study Site
Newark, New Jersey, 07102
United States
Atea Study Site
Newark, New Jersey, 07103
United States
Atea Study Site
Brooklyn, New York, 11215
United States
Atea Study Site
New York, New York, 10016
United States
Atea Study Site
Yonkers, New York, 10701
United States
Atea Study Site
Asheville, North Carolina, 28801
United States
Atea Study Site
Charlotte, North Carolina, 28204
United States
Atea Study Site
Fayetteville, North Carolina, 28304
United States
Atea Study Site
Beavercreek, Ohio, 45440
United States
Atea Study Site
Cincinnati, Ohio, 45267
United States
Atea Study Site
Tulsa, Oklahoma, 74104
United States
Atea Study Site
Allentown, Pennsylvania, 18103
United States
Atea Study Site
DuBois, Pennsylvania, 15801
United States
Atea Study Site
Philadelphia, Pennsylvania, 19104
United States
Atea Study Site
Philadelphia, Pennsylvania, 19107
United States
Atea Study Site
Charleston, South Carolina, 29425
United States
Atea Study Site
Chattanooga, Tennessee, 37421
United States
Atea Study Site
Cordova, Tennessee, 38018
United States
Atea Study Site
Jackson, Tennessee, 38301
United States
Atea Study Site
Arlington, Texas, 76012
United States
Atea Study Site
Dallas, Texas, 75203
United States
Atea Study Site
Dallas, Texas, 75242
United States
Atea Study Site
Denison, Texas, 75020
United States
Atea Study Site
Houston, Texas, 77030
United States
Atea Study Site
Plano, Texas, 75093
United States
Atea Study Site
San Antonio, Texas, 78215
United States
Atea Study Site
Temple, Texas, 76508
United States
Atea Study Site
Waco, Texas, 76710
United States
Atea Study Site
Ogden, Utah, 84405
United States
Atea Study Site
Chesapeake, Virginia, 23320
United States
Atea Study Site
Norfolk, Virginia, 23502
United States
Atea Study Site
Richmond, Virginia, 23226
United States
Atea Study Site
Richmond, Virginia, 23298
United States
Atea Study Site
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Atea Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-07
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-04-07
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • HEPATITIS C VIRUS CHRONIC INFECTION