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Report for Clinical Trial NCT01573351

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.

NCT01573351 Hepatitis C Virus
MeSH:Hepatitis C Hepatitis
HPO:Hepatitis

4 Interventions

Name: Asunaprevir

Type: Drug
Group Labels: 1

QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Name: Daclatasvir

Type: Drug
Group Labels: 1

QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Name: Peg-interferon Alfa-2a

Type: Drug
Group Labels: 1

QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Name: Ribavirin

Type: Drug
Group Labels: 1

QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Primary Outcomes

Measure: Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1

Time: At 12 weeks post-treatment

Secondary Outcomes

Measure: On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment

Time: Through the end of treatment (maximum up to 24 weeks) plus 7 days

Measure: Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene

Time: At post-treatment Week 12

Measure: Proportion of subjects with HCV RNA undetectable

Time: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24

Measure: Proportion of subjects with HCV RNA < LOQ

Time: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24)

Measure: Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects

Time: Post-treatment Week 12
Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP

SNPs

1 rs12979860

Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 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