SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01979939

Developed by Shray Alag, 2019.
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 Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic
HPO: Chronic active hepatitis Chronic hepatitis 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:
Chronic active hepatitis
Genes 5
KRT8 ALMS1 C4B KRT18 AIRE
Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG
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