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Report for Clinical Trial NCT01973049

Developed by Shray Alag, 2020.
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 A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO: 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/ 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:
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