To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
416
Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12
SVR12 is defined as HCV ribonucleic acid (RNA) \< limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12
Time frame: Post-Treatment Week 12
Proportion of subjects in the experienced cohort with SVR12
Time frame: Follow up Week 12
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND
Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND
Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24
Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort
Time frame: Up to post treatment week 4 (±7 days)
Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort
Time frame: Up to post treatment week 4 (±7 days)
Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort
Time frame: Up to post treatment week 4 (±7 days)
Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b
Time frame: Post treatment week 12
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Scripps Clinic
La Jolla, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
University Of Chicago Medical Center
Chicago, Illinois, United States
Indiana University Med Center
Indianapolis, Indiana, United States
...and 56 more locations
Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)
Time frame: Post treatment week 12
Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis
Time frame: Post treatment week 12