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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: Drug
Group Labels: 2

A 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 12

Secondary Outcomes

Measure: Proportion of subjects in the experienced cohort with SVR12

Time: Follow up Week 12

Measure: Proportion of subjects in each cohort who achieve HCV RNA Time: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

Measure: Proportion of subjects in each cohort who achieve HCV RNA Time: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24

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).



HPO Nodes


HPO: