SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01973049
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin
in treatment naive cirrhotic subjects.
Name: Daclatasvir
Type: Drug
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
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
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: Ribavirin
Type: Drug
A2: DCV/ASV/BMS-791325 + RBV (naive) A4: DCV/ASV/BMS-791325 + RBV (experienced)
Name: Placebo matching Ribavirin
Type: Drug
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 week
Secondary Outcomes
Measure: Proportion of treated subjects in each of the experienced arms with SVR12
Time: Post treatment 12 Week
Measure: 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).
HPO Nodes
HPO:Chronic active hepatitis
Genes 5
KRT8 ALMS1 C4B KRT18 AIRE hr>Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG hr>Hepatitis
Genes 74
TTC7A MST1 TRAF3IP2 TPP2 TBX19 IL12A MET IL12RB1 RASGRP1 TCF4 HSD3B7 KRT8 SERPINA1 TCF3 VIPAS39 ATP7A IGF2R MMEL1 ATP7B ALMS1 SPIB KRT18 VPS33B CIITA PDGFRL PIK3CA GPR35 CYP7A1 GUSB PIK3R1 AMACR RFXANK SHPK IGHM PIEZO1 SLC25A15 BTK IL21R CD40LG BLNK GLIS3 APC CLEC7A AIRE LRRC8A CASP8 POU2AF1 XIAP CASP10 C1S CYP7B1 PRKCD CD79A CD79B IRF5 C4B IL17RC IL17RA IGLL1 CTNNB1 FAS SKIV2L FASLG SH2D1A RFX5 IL17F RFXAP TNFSF15 TNPO3 PGM1 STAT1 TP53 AXIN1 FOXP3 hr>