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

Description

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

Conditions

HEPATITIS C VIRUS CHRONIC INFECTION

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

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

Condition
HEPATITIS C VIRUS CHRONIC INFECTION
Intervention / Treatment

-

Contacts and Locations

Birmingham

Atea Study Site, Birmingham, Alabama, United States, 35215

Dothan

Atea Study Site, Dothan, Alabama, United States, 36301

Washington

Atea Study Site, Washington, District of Columbia, United States, 20017

Coral Gables

Atea Study Site, Coral Gables, Florida, United States, 33134

Fort Pierce

Atea Study Site, Fort Pierce, Florida, United States, 34982

Inverness

Atea Study Site, Inverness, Florida, United States, 34452

Miami

Atea Study Site, Miami, Florida, United States, 33125

Tulsa

Atea Study Site, Tulsa, Oklahoma, United States, 74104

Chattanooga

Atea Study Site, Chattanooga, Tennessee, United States, 37421

Arlington

Atea Study Site, Arlington, Texas, United States, 76012

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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:
  • 1. Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and an undetectable plasma HIV-1 RNA level
  • 2. Suitable ARV treatment and not taking any contraindicated medications
  • * Pregnant or breastfeeding
  • * Co-infected with hepatitis B virus
  • * Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
  • * Requirement of any prohibited medications
  • * Use of other investigational drugs within 30 days of dosing
  • * History or signs of decompensated liver disease (decompensated cirrhosis)
  • * History of hepatocellular carcinoma (HCC)
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Atea Pharmaceuticals, Inc.,

Study Record Dates

2026-12