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Report for Clinical Trial NCT01797848

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4

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

NCT01797848 Hepatitis C
MeSH:Hepatitis C Hepatitis
HPO:Hepatitis

4 Interventions

Name: Peginterferon alfa 2a

Type: Drug
Group Labels: 2

pegIFNα 2a + Ribavirin + Daclatasvir pegIFNα 2a + Ribavirin + Placebo

Name: Ribavirin

Type: Drug
Group Labels: 2

pegIFNα 2a + Ribavirin + Daclatasvir pegIFNα 2a + Ribavirin + Placebo

Name: Placebo matching Daclatasvir

Type: Drug
Group Labels: 1

pegIFNα 2a + Ribavirin + Placebo

Name: Daclatasvir

Type: Drug
Group Labels: 1

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:
HP:0012115: Hepatitis
Genes 91
TNPO3 AIRE CD247 PIK3R1 ATP7A TRAF3IP2 APC COG6 PGM1 C4B PIEZO1 AXIN1 COG8 POU2AF1 CD79A IL17RC TNFSF15 CD40LG TCF4 ITCH SKIV2L CYP7A1 IL17F BLNK TPP2 RFXAP TCF3 VPS33B SLC25A15 C1S CLEC7A FAS HSD3B7 KRT18 GUSB FASLG ALMS1 CYP7B1 CIITA TBX19 XIAP TP53 BTK LRRC8A RASGRP1 CASP10 CD3E PIK3CA XIAP VIPAS39 FOXP3 TTC7A TTC7A STAT1 IL12RB1 RFXANK IRF5 SH2D1A IL21R MST1 RFXANK CD3D CASP8 AMACR MMEL1 IL12A CD79B IGHM GLIS3 SHPK CIITA FAS MET IL17RA RFXAP IGLL1 SPIB KRT8 ATP7B BTK IGF2R PDGFRL RFX5 RFX5 ATP7B BTK GPR35 SERPINA1 PRKCD CTNNB1 SLC25A15
Protein Mutations 29
A181V A92T C282Y E62D G1764A H54Y H58C H63D L28M L31M L528M M204I M204V M28L M552I M552V N236T N370S P1028S P58A Q215S Q30H Q54H Q62E Q80K R30H Y93C Y93F Y93H
SNP 20
rs10813831 rs1127354 rs11795404 rs12356193 rs12979860 rs12992677 rs17037122 rs179008 rs2066842 rs2067085 rs2464266 rs3853839 rs41308230 rs4588 rs5743844 rs6592052 rs7041 rs7270101 rs7549785 rs8099917