SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01797848
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The purpose of this study is to determine whether 24 week treatment with the Daclatasvir
(DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is
safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24)
(defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks
of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects
Name: Peginterferon alfa 2a
Type: Drug
pegIFNα 2a + Ribavirin + Placebo pegIFNα 2a + Ribavirin + Daclatasvir
Name: Ribavirin
Type: Drug
pegIFNα 2a + Ribavirin + Placebo pegIFNα 2a + Ribavirin + Daclatasvir
Name: Placebo matching Daclatasvir
Type: Drug
pegIFNα 2a + Ribavirin + Placebo
Name: Daclatasvir
Type: Drug
pegIFNα 2a + Ribavirin + Daclatasvir
Primary Outcomes
Measure: Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort
Time: Week 24 post treatment follow up
Secondary Outcomes
Measure: Proportion of Genotype (GT) 4 subjects with SVR24
Time: Week 24 post treatment follow up visit
Measure: Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable
Time: Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)
Measure: Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)
Time: Up to 48 weeks plus 30 days
Measure: Discontinuations due to Adverse Events (AEs)
Time: Up to 48 weeks plus 7 days
Measure: Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene
Time: Up to 72 weeks
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs12979860
Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene.
HPO Nodes
HPO: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>