Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Phase 3

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

NCT06868264 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2025-04-07
Last updated
2025-12-05

Condition(s) studied

HEPATITIS C VIRUS CHRONIC INFECTION

Investigational drug(s) / intervention(s)

Bemnifosbuvir-Ruzasvir (BEM/RZR) →Sofosbuvir-Velpatasvir (SOF/VEL) →

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)

Sofosbuvir-Velpatasvir (SOF/VEL): SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Key Inclusion 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 plasma HIV-1 RNA \<LLOQ 2. Suitable ARV treatment and not taking any contraindicated medications Key Exclusion Criteria: * 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

Primary outcome measure(s)

  • Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24. — Day 1 through Week 24

Trial sites (105)

FacilityCityRegionStatus
Atea Study Site Birmingham Alabama
Atea Study Site Dothan Alabama
Atea Study Site Chandler Arizona
Atea Study Site Flagstaff Arizona
Atea Study Site Mesa Arizona
Atea Study Site Phoenix Arizona
Atea Study Site Phoenix Arizona
Atea Study Site Tucson Arizona
Atea Study Site Little Rock Arkansas
Atea Study Site Bakersfield California
Atea Study Site Coronado California
Atea Study Site Escondido California
Atea Study Site Fresno California
Atea Study Site Long Beach California
Atea Study Site Los Angeles California
Atea Study Site Los Angeles California
Atea Study Site Orange California
Atea Study Site Pasadena California
Atea Study Site Sacramento California
Atea Study Site Torrance California
Atea Study Site Valencia California
Atea Study Site Colorado Springs Colorado
Atea Study Site Washington D.C. District of Columbia
Atea Study Site Washington D.C. District of Columbia
Atea Study Site Coral Gables Florida
Atea Study Site DeLand Florida
Atea Study Site Fort Lauderdale Florida
Atea Study Site Ft. Pierce Florida
Atea Study Site Gainesville Florida
Atea Study Site Inverness Florida
Atea Study Site Jupiter Florida
Atea Study Site Lauderdale Lakes Florida
Atea Study Site Maitland Florida
Atea Study Site Miami Florida
Atea Study Site Miami Lakes Florida
Atea Study Site Orlando Florida
Atea Study Site Pembroke Pines Florida
Atea Study Site Sarasota Florida
Atea Study Site West Palm Beach Florida
Atea Study Site Macon Georgia

+ 65 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06868264 on ClinicalTrials.gov ↗ ← All trials in Canada