This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
275
550 mg administered orally once a day (QD) for 8 weeks
180 mg administered orally once a day (QD) for 8 weeks
Percentage of Subjects Achieving Sustained Virologic Response at 12 Weeks Post-treatment (SVR12)
SVR12 defined as plasma hepatitis C virus (HCV) RNA less than the lower limit of quantitation (\<LLOQ) at 12 weeks post-treatment
Time frame: Day 1 through 12 weeks after end of treatment
Percentage of Subjects Experiencing Virologic Failure
Virologic failure defined as a confirmed 1 log10 increase in HCV RNA from post-baseline nadir, or confirmed increase in HCV RNA ≥ LLOQ in any subject who achieved HCV RNA \< LLOQ.
Time frame: Day 1 through 12 weeks after end of treatment
Percentage of Subjects Achieving Sustained Virologic Response at 24 Weeks Post-treatment (SVR24)
SVR24 defined as plasma HCV RNA less than the lower limit of quantitation (\<LLOQ) at 24 weeks post-treatment
Time frame: Day 1 through 24 weeks after end of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Atea Study Site
San Antonio, Texas, United States
Atea Study Site
Manaus, Amazonas, Brazil
Atea Study Site
Salvador, Estado de Bahia, Brazil
Atea Study Site
Brasília, Federal District, Brazil
Atea Study Site
Rio de Janeiro, Rio Do Janeiro, Brazil
Atea Study Site
Porto Alegre, Rio Grande do Sul, Brazil
Atea Study Site
Porto Alegre, Rio Grande do Sul, Brazil
Atea Study Site
Porto Velho, Rondônia, Brazil
Atea Study Site
Boa Vista, Roraima, Brazil
Atea Study Site
Botucatu, São Paulo, Brazil
...and 41 more locations