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Report for Clinical Trial NCT01497834

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

NCT01497834 Hepatitis C
MeSH:Hepatitis A Hepatitis C Hepatitis
HPO:Hepatitis

2 Interventions

Name: BMS-790052 (Daclatasvir)

Description: Tablets, Oral, 60mg, Once daily, 24 weeks
Type: Drug
Group Labels: 1

Daclatasvir + Asunaprevir

Name: BMS-650032 (Asunaprevir)

Description: Capsules, Oral, 100mg, Twice daily, 24 weeks
Type: Drug
Group Labels: 1

Daclatasvir + Asunaprevir

Primary Outcomes

Description: SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)

Measure: Antiviral activity, as determined by the proportion of subjects with SVR24

Time: After 24 weeks of the last dose

Secondary Outcomes

Measure: Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected

Time: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12

Measure: Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected

Time: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24

Measure: Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade

Time: End of treatment plus 7 days

Measure: Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]

Time: Follow-up Week 24
Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP

SNPs

1 rs12979860

Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)].


HPO Nodes

HPO:
HP:0012115: Hepatitis
Genes 91
TNPO3 AIRE CD247 PIK3R1 ATP7A TRAF3IP2 APC COG6 PGM1 C4B PIEZO1 AXIN1 COG8 POU2AF1 CD79A IL17RC TNFSF15 CD40LG TCF4 ITCH SKIV2L CYP7A1 IL17F BLNK TPP2 RFXAP TCF3 VPS33B SLC25A15 C1S CLEC7A FAS HSD3B7 KRT18 GUSB FASLG ALMS1 CYP7B1 CIITA TBX19 XIAP TP53 BTK LRRC8A RASGRP1 CASP10 CD3E PIK3CA XIAP VIPAS39 FOXP3 TTC7A TTC7A STAT1 IL12RB1 RFXANK IRF5 SH2D1A IL21R MST1 RFXANK CD3D CASP8 AMACR MMEL1 IL12A CD79B IGHM GLIS3 SHPK CIITA FAS MET IL17RA RFXAP IGLL1 SPIB KRT8 ATP7B BTK IGF2R PDGFRL RFX5 RFX5 ATP7B BTK GPR35 SERPINA1 PRKCD CTNNB1 SLC25A15
Protein Mutations 29
A181V A92T C282Y E62D G1764A H54Y H58C H63D L28M L31M L528M M204I M204V M28L M552I M552V N236T N370S P1028S P58A Q215S Q30H Q54H Q62E Q80K R30H Y93C Y93F Y93H
SNP 20
rs10813831 rs1127354 rs11795404 rs12356193 rs12979860 rs12992677 rs17037122 rs179008 rs2066842 rs2067085 rs2464266 rs3853839 rs41308230 rs4588 rs5743844 rs6592052 rs7041 rs7270101 rs7549785 rs8099917