https://clinicaltrials.gov/study/NCT06868264
Brief Summary
The purpose of this study is to compare the efficacy and safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) administered once daily (QD) for 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis) versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) administered for 12 weeks QD in adults with chronic Hepatitis C Virus.
Who can take part? Adults : * 18 to 85 years of age, * have chronic HCV infection, and * do not have a hepatitis B virus (HBV) infection. Other criteria apply.
What else to consider?
The C-BEYOND Study is comparing the safety and effectiveness of an investigational drug (study drug) with another drug (comparator drug). The comparator drug is a generic version of a drug approved in the United States and Canada to treat HCV, but this generic version being used in the study has only been approved in the United States. The study drug is investigational, and it is not approved for the treatment of HCV infection. There is no obligation to take part in the study. While current HCV treatments work, they may not be suitable for all patients with HCV. If someone takes part, they will be in the C-BEYOND Study for about 9.5 months. They will need to: * visit the study center up to 10 times for tests and assessments, and * take the study drug or comparator drug by mouth every day for 8 or 12 weeks.
Study participation is voluntary. By contacting us, you are under no obligation to take part in the study.
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
- Location:
- Torrance
- Status:
- Recruiting
- Study Type:
- Interventional
- Phase:
- 3