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Report for Clinical Trial NCT01979939

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C

To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

NCT01979939 Hepatitis C
MeSH: Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO: Hepatitis

1 Interventions

Name: DCV/ASV/BMS-791325

Type: Drug

A 1: DCV/ASV/BMS-791325 in treatment-naive subjects A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects


Primary Outcomes

Description: SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12

Measure: Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12

Time: Post-Treatment Week 12

Secondary Outcomes

Measure: Proportion of subjects in the experienced cohort with SVR12

Time: Follow up Week 12

Measure: Proportion of subjects in each cohort who achieve HCV RNA Time: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

Measure: Proportion of subjects in each cohort who achieve HCV RNA Time: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24

Measure: Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort

Time: Up to post treatment week 4 (±7 days)

Measure: Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort

Time: Up to post treatment week 4 (±7 days)

Measure: Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort

Time: Up to post treatment week 4 (±7 days)

Measure: Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b

Time: Post treatment week 12

Measure: Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)

Time: Post treatment week 12

Measure: Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis

Time: Post treatment week 12

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype).



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