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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

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

Name: Ribavirin

Type: Drug

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

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 90
CD247 CTNNB1 ATP7B CASP10 PIEZO1 GUSB BLNK SHPK CYP7A1 IL17RA IGF2R CASP8 SH2D1A SLC25A15 BTK BTK C4B CD79B VPS33B XIAP SERPINA1 PIK3R1 GLIS3 POU2AF1 CIITA FOXP3 TPP2 RFX5 CIITA RASGRP1 RFXANK SLC25A15 AXIN1 TCF4 CD3D TP53 IL12A PRKCD CD40LG BTK IGHM IL17RC ALMS1 TRAF3IP2 KRT8 FAS LRRC8A FAS IL17F XIAP SPIB C1S RFX5 RFXAP MST1 TTC7A COG8 SKIV2L VIPAS39 IGLL1 PDGFRL TNFSF15 HSD3B7 CD3E AMACR ATP7B FASLG RFXANK IL12RB1 TCF3 CD79A KRT18 IRF5 MET PIK3CA MMEL1 ITCH TBX19 IL21R AIRE RFXAP TTC7A CLEC7A GPR35 ATP7A CYP7B1 STAT1 PGM1 APC TNPO3