SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT02496078
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The purpose of this study is to determine whether a regimen consisting of daclatasvir and
asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b
infection.
Name: Daclatasvir
Description: Daclatasvir tablet 60mgType: Drug
Active dual arm Placebo arm
Name: Asunaprevir
Description: Asunaprevir soft capsule 100 mgType: Drug
Active dual arm Placebo arm
Primary Outcomes
Description: HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12
Measure: Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)
Time: Post-treatment Week 12
Secondary Outcomes
Measure: Proportion of subjects with anemia on active Dual therapy
Time: Post-treatment Week 12
Measure: Proportion of subjects with neutropenia on active Dual therapy
Time: Post-treatment Week 12
Measure: Proportion of subjects with thrombocytopenia on active Dual therapy
Time: Post-treatment Week 12
Measure: On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time: Post-treatment week 12
Measure: Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)
Time: first 12 weeks on treatment
Measure: Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)
Time: first 12 weeks on treatment
Measure: Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort
Time: Post-treatment visit week 12
Measure: Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy
Time: post-treatment visit Week 24
Measure: Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy
Time: post-treatment visit Week 24
Measure: Proportion of treated subjects with SVR12 for subjects randomized to placebo
Time: Post-treatment visit week 12
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs12979860
Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort.
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>