SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01973049

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

NCT01973049 Hepatitis C
MeSH: Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic
HPO: Chronic active hepatitis Chronic hepatitis Hepatitis

5 Interventions

Name: Daclatasvir

Type: Drug

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BMS-791325 + RBV (experienced)

Name: Asunaprevir

Type: Drug

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BMS-791325 + RBV (experienced)

Name: BMS-791325

Type: Drug

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BMS-791325 + RBV (experienced)

Name: Ribavirin

Type: Drug

A2: DCV/ASV/BMS-791325 + RBV (naive) A4: DCV/ASV/BMS-791325 + RBV (experienced)

Name: Placebo matching Ribavirin

Type: Drug

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)


Primary Outcomes

Description: SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) < Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)

Measure: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12)

Time: Post treatment 12 week

Secondary Outcomes

Measure: Proportion of treated subjects in each of the experienced arms with SVR12

Time: Post treatment 12 Week

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

Time: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

Measure: Proportion of subjects in each arm who achieve HCV RNA < LOQ TND

Time: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)

Measure: Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs)

Time: Up to end of treatment (week 12) + 7 days

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

Time: Up to end of treatment (week 12) + 7 days

Measure: Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities

Time: Up to end of treatment (week 12) + 7 days

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

Time: Post treatment 12 Week

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

Time: Post treatment 12 Week

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Proportion of subjects in each arm 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