C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV
NCT06868264 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 880
Last updated 2025-12-05
Summary
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
Interventions
- DRUG
-
Bemnifosbuvir-Ruzasvir (BEM/RZR)
BEM/RZR Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis)
- DRUG
-
Sofosbuvir-Velpatasvir (SOF/VEL)
SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
Sponsors & Collaborators
-
Atea Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-07
- Primary Completion
- 2026-09-30
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
More Related Trials
-
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
NCT02671500 ·Status: COMPLETED ·Phase: PHASE3
-
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
NCT02822794 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
NCT02536313 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
NCT02722837 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
NCT01858766 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
NCT02994056 ·Status: COMPLETED ·Phase: PHASE2
-
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
NCT02607800 ·Status: COMPLETED ·Phase: PHASE3
-
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
NCT02226549 ·Status: COMPLETED ·Phase: PHASE2
-
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
NCT02346721 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
NCT02300103 ·Status: COMPLETED ·Phase: PHASE2
-
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
NCT02201901 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
NCT01826981 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
NCT01768286 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT02639338 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
NCT01909804 ·Status: COMPLETED ·Phase: PHASE2
-
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
NCT02201940 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT04211909 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
NCT04112303 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
NCT02607735 ·Status: COMPLETED ·Phase: PHASE3
-
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT03074331 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
NCT02640157 ·Status: COMPLETED ·Phase: PHASE3
-
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
NCT02728206 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
NCT02745535 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
NCT02639247 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
NCT02021643 ·Status: COMPLETED ·Phase: PHASE3