The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.
Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study) Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
748
Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive
Time frame: At 12 weeks post-treatment
Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R
Time frame: Post-treatment Week 12
On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)
Time frame: End of Treatment (up to 48 weeks) plus 7 days
Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects
Time frame: Up to first 12 weeks
Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort
Time frame: Post-treatment Week 12
Proportion of genotype 1b subjects with HCV RNA undetectable
eRVR = Extended rapid virologic response, EOT = End of treatment
Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort
Proportion of genotypes 1b subjects with HCV RNA < LOQ
Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort
Proportion of subjects with anemia
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The Health Care Authority For Baptist Health
Montgomery, Alabama, United States
Scripps Clinic
La Jolla, California, United States
Scpmg/ Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
University Of Colorado Denver And Hospital
Aurora, Colorado, United States
Uf Hepatology Research At Ctrb
Gainesville, Florida, United States
Johns Hopkins Medical Institutions
Lutherville, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
North Shore-Long Island Jewish Health System
Manhasset, New York, United States
...and 106 more locations
Time frame: At 12 weeks post-treatment
Proportion of subjects with rash
Time frame: At 12 weeks post-treatment