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Report for Clinical Trial NCT01973049
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
NCT01973049 Hepatitis C MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis
5 Interventions
Name: Daclatasvir
Type: Drug
Group Labels: 4 A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BMS-791325 + RBV (experienced)
Name: Asunaprevir
Type: Drug
Group Labels: 4 A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BMS-791325 + RBV (experienced)
Name: BMS-791325
Type: Drug
Group Labels: 5 A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BM A4: DCV/ASV/BMS-791325 + RBV (experienced)
Name: Ribavirin
Type: Drug
Group Labels: 2 A2: DCV/ASV/BMS-791325 + RBV (naive) A4: DCV/ASV/BMS-791325 + RBV (experienced)
Name: Placebo matching Ribavirin
Type: Drug
Group Labels: 2 A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)
Primary Outcomes
Description: SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) < Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)
Measure: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) Time: Post treatment 12 weekSecondary Outcomes
Measure: Proportion of treated subjects in each of the experienced arms with SVR12 Time: Post treatment 12 WeekMeasure: Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND Time: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Measure: Proportion of subjects in each arm who achieve HCV RNA < LOQ TND Time: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)
Measure: Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs) Time: Up to end of treatment (week 12) + 7 days
Measure: Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort Time: Up to end of treatment (week 12) + 7 days
Measure: Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities Time: Up to end of treatment (week 12) + 7 days
Measure: Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b Time: Post treatment 12 Week
Measure: Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype) Time: Post treatment 12 Week
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs12979860
Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype).