The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
880
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)
Time frame: Post-treatment follow-up week 12
Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]
Time frame: On-treatment Week 4
Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)
Hb = Hemoglobin ANC = Absolute neutrophil count
Time frame: Up to week 12 or week 24
Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)
Time frame: Up to week 12 or week 24
Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
Time frame: Up to week 12 or week 24
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group
Time frame: Post-treatment week 24
Proportion of subjects with on-treatment Serious adverse events (SAEs)
Time frame: Up to week 12 or week 24
Proportion of subjects with dose reductions
Time frame: Up to week 12 or week 24
Proportion of subjects who discontinue due to Adverse events (AEs)
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Tablets, Oral, 400 mg, Twice daily, 24 weeks
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Tablets, Oral, 60 mg, Once daily, 12 weeks
Tablets, Oral, 0 mg, Once daily, 12 weeks
Mayo Clinic Arizona
Phoenix, Arizona, United States
Precision Research Institute, Llc
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
University Of California, San Francisco/Sf General Hospital
San Francisco, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Orlando Immunology Center
Orlando, Florida, United States
Orlando Infectious Disease Center
Orlando, Florida, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
The Queen'S Liver Center
Honolulu, Hawaii, United States
...and 114 more locations
Time frame: Up to week 12 or week 24
Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection
Time frame: Post-treatment follow-up week 12
Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)
Time frame: Up to week 12 or week 24