SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT01573351

Developed by Shray Alag, 2019.
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 Hepatitis C
HPO: Hepatitis

4 Interventions

Name: Asunaprevir

Type: Drug

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

Name: Daclatasvir

Type: Drug

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

Name: Peg-interferon Alfa-2a

Type: Drug

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

Name: Ribavirin

Type: Drug

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

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:
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