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Report for Clinical Trial NCT02496078

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.

NCT02496078 Hepatitis C
MeSH: Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO: Hepatitis

2 Interventions

Name: Daclatasvir

Description: Daclatasvir tablet 60mg

Type: Drug

Active dual arm Placebo arm

Name: Asunaprevir

Description: Asunaprevir soft capsule 100 mg

Type: Drug

Active dual arm Placebo arm

Primary Outcomes

Description: HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12

Measure: Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)

Time: Post-treatment Week 12

Secondary Outcomes

Measure: Proportion of subjects with anemia on active Dual therapy

Time: Post-treatment Week 12

Measure: Proportion of subjects with neutropenia on active Dual therapy

Time: Post-treatment Week 12

Measure: Proportion of subjects with thrombocytopenia on active Dual therapy

Time: Post-treatment Week 12

Measure: On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

Time: Post-treatment week 12

Measure: Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)

Time: first 12 weeks on treatment

Measure: Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)

Time: first 12 weeks on treatment

Measure: Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort

Time: Post-treatment visit week 12

Measure: Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy

Time: post-treatment visit Week 24

Measure: Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy

Time: post-treatment visit Week 24

Measure: Proportion of treated subjects with SVR12 for subjects randomized to placebo

Time: Post-treatment visit week 12
Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP

SNPs

1 rs12979860

Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort.


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