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Report for Clinical Trial NCT01979939
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
NCT01979939 Hepatitis C MeSH: Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO: Hepatitis
1 Interventions
Name: DCV/ASV/BMS-791325
Type: DrugA 1: DCV/ASV/BMS-791325 in treatment-naive subjects A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects
Primary Outcomes
Description: 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
Measure: Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 Time: Post-Treatment Week 12Secondary Outcomes
Measure: Proportion of subjects in the experienced cohort with SVR12 Time: Follow up Week 12Measure: Proportion of subjects in each cohort who achieve HCV RNA
Measure: Proportion of subjects in each cohort who achieve HCV RNA
Measure: Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort Time: Up to post treatment week 4 (±7 days)
Measure: Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort Time: Up to post treatment week 4 (±7 days)
Measure: Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort Time: Up to post treatment week 4 (±7 days)
Measure: Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b Time: Post treatment week 12
Measure: Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype) Time: Post treatment week 12
Measure: Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis Time: Post treatment week 12
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs12979860
Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype).