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Report for Clinical Trial NCT02170727
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
NCT02170727 Hepatitis C Virus MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis
1 Interventions
Name: DCV/ASV/BMS-791325
Primary Outcomes
Description: Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Measure: Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort Time: Post treatment Week 12Secondary Outcomes
Description: Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LLOQ target detected or target not detected (LLOQ TD/TND).
Measure: Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort Time: Post treatment Week 12Description: 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, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).
Measure: Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND Time: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)Description: Percentage of treated participants with HCV RNA < LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.
Measure: Percentage of Participants Who Achieved HCV RNA < LLOQ TND Time: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)Description: 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.
Measure: Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment Time: Up to post treatment week 4Description: Anemia was defined as hemoglobin < 10 g/dL on-treatment for subjects who had hemoglobin >= 10 g/dL at baseline.
Measure: Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline Time: Up to post treatment week 4Description: Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
Measure: Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b Time: Post treatment week 12Description: Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Measure: Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) Time: Post treatment Week 12Description: Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
Measure: Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 Time: Post treatment Week 12Description: Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
Measure: Number of Participants With Selected Grade 3/4 Laboratory Abnormalities Time: Post treatment week 4Description: Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
Measure: Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs Time: Up to post treatment week 4Description: Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.
Measure: Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities Time: Up to post treatment week 4Purpose: Treatment
Allocation: N/A
Single Group Assignment
There is one SNP
SNPs
1 rs12979860
Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.. Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype).
Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.. Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12.