SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02170727

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1

To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

NCT02170727 Hepatitis C Virus
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

Arm 1 : DCV/ASV/BMS-791325


Primary Outcomes

Description: Proportion of treated subjects with Sustained virologic response 12 (SVR12) in the naive cohort, defined as HCV RNA < LOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12

Measure: Proportion of treated subjects with SVR12 in the naive cohort

Time: Post treatment Week 12

Secondary Outcomes

Description: Proportion of treated subjects with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND)

Measure: Proportion of treated subjects with SVR12 in the IFNα experienced cohort

Time: Post treatment Week 12

Measure: Proportion of subjects in each cohort who achieve HCV RNA < LOQ TD/TND

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 < LOQ TND

Time: Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12 and 24

Measure: Safety in each cohort, as measured by frequency of serious adverse events(SAEs), discontinuations due to AEs, and selected Grade 3-4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria)

Time: Up to post treatment week 4

Measure: Proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who have Hb ≥10 g/dL at baseline in each cohort

Time: Up to post treatment week 4

Measure: Proportion of subjects in each cohort achieving SVR12 associated with hepatitis C virus (HCV) genotype subtype 1a vs 1b

Time: Post treatment week 12

Measure: Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype)

Time: Post treatment Week 12

Measure: Proportion of cirrhotic and non cirrhotic subjects who achieve SVR12

Time: Post treatment Week 12

Measure: Safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to adverse events (AEs), and selected Grade 3 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria)

Time: Post treatment week 4

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 rs12979860

Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 Single Nucleotide Polymorphisms (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