To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
202
Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12)
SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) \< Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)
Time frame: Post treatment 12 week
Proportion of treated subjects in each of the experienced arms with SVR12
Time frame: Post treatment 12 Week
Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND
Time frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Proportion of subjects in each arm who achieve HCV RNA < LOQ TND
Time frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)
Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs)
Time frame: Up to end of treatment (week 12) + 7 days
Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort
Time frame: Up to end of treatment (week 12) + 7 days
Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities
Time frame: Up to end of treatment (week 12) + 7 days
Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b
Time frame: Post treatment 12 Week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Chicago, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
...and 39 more locations
Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype)
Time frame: Post treatment 12 Week