The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.
Allocation: Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention groups by chance Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method such as physician choice Number of Arms: Initial Therapy: 2 Groups Rescue Therapy: 2 Groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Inland Empire Liver Foundation
Rialto, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
Indiana University Health - University Hospital
Indianapolis, Indiana, United States
Percentage of Participants With Sustained Virologic Response 12 (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach.
Time frame: 12 Weeks after treatment discontinuation (Follow-up Week 12)
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
Time frame: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.
Time frame: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Percentage of Participants With End of Treatment Response (EOTR)
EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.
Time frame: End of the treatment
Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND
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Indiana University Med Center
Indianapolis, Indiana, United States
Johns Hopkins University
Lutherville, Maryland, United States
Texas Liver Institute
San Antonio, Texas, United States
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24).
Time frame: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24).
Time frame: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24
Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b
Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b
Time frame: Post-treatment Week 12
Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)
Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Time frame: Post-treatment Week 12