SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02806362

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease on Hemodialysis (GIFT-R)

The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.

NCT02806362 Chronic Hepatitis C Virus
MeSH: Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Kidney Diseases Kidney Failure, Chronic
HPO: Abnormality of the kidney Chronic active hepatitis Chronic hepatitis Hepatitis Nephropathy

1 Interventions

Name: Ombitasvir/paritaprevir/ritonavir

Description: Tablet

Type: Drug

Ombitasvir/paritaprevir/ritonavir (12 weeks)


Primary Outcomes

Description: SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.

Measure: Percentage of participants achieving a 12-week sustained virologic response (SVR12).

Time: 12 weeks after the last dose of study drug

Secondary Outcomes

Description: On-treatment virologic failure was defined as the following: Confirmed increase from nadir in HCV RNA (2 consecutive HCV RNA measurements greater than 1 log10 IU/mL above nadir) at any time point during treatment; or Confirmed HCV RNA greater than or equal to LLOQ after HCV RNA is less than LLOQ during treatment; or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks of treatment.

Measure: Percentage of participants with on-treatment virologic failure

Time: Up to Week 12

Description: Participants with a confirmed HCV RNA greater than or equal to the LLOQ between Final treatment visit and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA less than LLOQ at Final treatment visit.

Measure: Percentage of participants with relapse

Time: Up to 12 weeks after the last dose of study drug

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 Y93H

Exclusion Criteria: - Presence of Y93H variant at Screening - Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human immunodeficiency virus antibody (HIV Ab) - Significant liver disease with any cause other than chronic HCV infection - On peritoneal dialysis - On hemodialysis for more than 15 years Inclusion Criteria: - Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile - Hepatitis C Virus (HCV) Ribonucleic acid (RNA) greater than 10,000 IU/mL at Screening - Chronic HCV, Genotype (GT)1b infection - Treatment-naive or treatment-experienced with an interferon (IFN)-containing regimen (IFN or pegylated-IFN with or without ribavirin). --- Y93H ---

Exclusion Criteria: - Presence of Y93H variant at Screening - Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human immunodeficiency virus antibody (HIV Ab) - Significant liver disease with any cause other than chronic HCV infection - On peritoneal dialysis - On hemodialysis for more than 15 years Chronic Hepatitis C Virus Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Kidney Diseases Kidney Failure, Chronic null --- Y93H ---



HPO Nodes


HPO:
Abnormality of the kidney
Genes 1011
MKKS TACO1 RPL26 NRIP1 ERBB3 CTU2 SLC29A3 SF3B4 AMER1 BRIP1 ERCC4 ERCC6 NUP85 CWC27 MARS USP9X RBM10 SMC1A MAX ACP5 APC2 TMEM216 ACTB ETFA ETFB SLC6A19 ZFP57 ETFDH CD109 COQ8B NAA10 ACTG1 ACTG2 EVC DHDDS LAGE3 MCM5 IKZF1 ACTN4 CD46 EXT2 RPS26 EYA1 ACVRL1 MDH2 RREB1 ARID1A MDM2 F2 ADA IL17F MECP2 KLRC4 F10 IFT43 MEFV PHF21A RYR1 MAP3K1 TBC1D24 AXIN2 BAP1 MEN1 MEOX1 FANCA FANCC FANCD2 GREB1L FANCE SEMA3A ARL6 ACSL4 FAH TTC8 MET FANCB DACT1 FANCF FANCG SAA1 ARID1B FBN1 DLC1 SALL1 KITLG MBTPS2 SC5D COG6 FKTN YAP1 STRADA HOGA1 JAG1 AGT AGTR1 AGXT NR0B1 MITF GPC4 SCNN1A SCNN1B WDR35 FGA MLH1 SCNN1G SCO1 CC2D2A ANTXR1 KMT2A FGF8 AKT1 FGF10 FGFR1 FGFR3 FGFR2 IFT80 MAD2L2 TP53RK SLITRK6 FH SLC30A9 ALDOB LTBP4 MOCS1 ALOX12B FOXG1 MOCS2 SEC23B SDHA FOXF1 SDHB SDHC ZNF687 SDHD ALPL OPLAH FOXI1 CRTAP FOXC2 FOXE1 FLI1 FLII FLNA FLNB KLF11 DCDC2 FRAS1 FBLN5 CCDC22 DEAF1 FN1 OFD1 OSTM1 CISD2 SFTPC PUF60 FOS PEX3 CEP290 AGPAT2 ARX KCNAB2 BBIP1 APC ITGA8 TMEM138 SHH ELP1 AIRE FUZ NTNG1 SI UQCC2 DGKE APOA1 APOB LIPN MSH2 CHD7 FASTKD2 MSH3 POMT1 TMEM107 STIL APOE OSGEP SIX1 SIX3 FANCM APRT SKI PIGV FAS FASLG CCDC141 TMEM127 AQP2 SLC1A1 AR COA8 ABCC6 CEP164 SLC2A2 PEX26 SLC3A1 SLC4A1 EPG5 SLC5A2 FAN1 CEP63 SDR9C7 WDR19 MST1 ARHGDIA SETD2 VAC14 RAB3GAP1 ARL3 RAB18 PIGT VIPAS39 NPHP3 PIEZO2 STS ATP6 SLC12A1 SLC12A3 COX1 COX2 UBE2T G6PC3 COX3 ARVCF WDR11 FEZF1 SLC34A1 DYNC2LI1 TRIM32 TP63 ND1 ND2 ND3 XPNPEP3 EBP ND4 ND5 ND6 CLDN16 SNAI2 DCHS1 NUP133 B9D1 SMARCA4 RSPO2 SMARCB1 FLCN SMARCC2 SIX5 CDK5RAP2 TRNE SMARCE1 TRNF SMS CEP152 NR5A1 TRNH IFT122 TRNK TRNL1 RERE TRNN ATP1A1 TRNQ MAPKBP1 TRNS1 SLC4A4 TRNS2 OCLN TRNT TRNV FUT8 TRNW SUFU SNRPB FXYD2 MUC1 MCTP2 PRDM16 BBS12 G6PC SLC37A4 TRIM37 SLX4 MMUT H19 AFF4 RAI1 MGME1 INVS SON RAB23 GABRD ADCY10 TRAF3IP2 SOX9 MYD88 SOX10 UBR1 SOX11 ATP6V1B1 DNAJB11 INTU MYH9 MYH11 ANKS6 ATP7A DIS3L2 CENPJ ATP7B WWOX MYLK GALNT3 WDR4 ATRX MYO1E CHST14 MYO5B ERAP1 AVPR2 ZNF423 NADK2 SDCCAG8 DZIP1L B2M KIF1B TMEM126B IQSEC2 SRC GAS1 HDAC8 GATA3 GATA4 GBA BBS1 BBS2 SPART GBE1 CDH23 BBS4 SRP54 NBN SRY CCND1 GCK COL25A1 SSR4 SMOC1 PEX11B SRCAP GDF2 COQ2 ANKLE2 GPKOW ADA2 BCS1L BBS9 NDUFB8 SLC26A1 NDUFS2 HESX1 FREM1 STAT1 FGF17 STAT3 STAT4 STAT5B NUP205 NOD2 BLK LPIN1 IFIH1 CDKL5 STK11 BMP4 NEK1 NEUROD1 STX3 GANAB KISS1R TXNL4A NF1 PNPLA6 STXBP1 GLA GPC3 BRCA1 BRAF BRCA2 MAGED2 SULT2B1 NFIA KLHL7 SGPL1 GLI1 GLI2 GLI3 ABCC8 SURF1 GLIS2 BUB1 BUB1B VAMP7 C1QBP MYMK HYLS1 C1QA C1QB C1QC C3 LIPT2 GNA11 C4A TACR3 BMPER GNAS STRA6 GNB1 FOXH1 TAF13 MAP3K7 NODAL KCNQ1OT1 TALDO1 KYNU NUP160 ABCG5 ABCG8 TBX1 ALG1 NOTCH2 NOTCH3 CA2 GP1BA GP1BB SPINK5 GP9 TBX15 NPHP1 NPHS1 NPM1 CACNA1D CACNA1S IFT27 TCF4 TBX3 NCAPD3 NIPAL4 HNF1A HNF1B SLC25A20 ADAMTSL1 CAD RPGRIP1L NRAS B4GAT1 TCN2 GPR35 ROR2 NUMA1 SOX17 NSD1 BAZ1B CASP10 CASR IL17RC ADAMTS13 RIPK4 TDGF1 LMNB2 OCRL SPECC1L AIP CAV1 BBS5 SLC7A7 SERPINH1 NXN OGG1 CIT TFAP2A DICER1 CLDN10 GSN TFE3 ZFPM2 POLR3A CCND2 SLC7A9 GRIP1 TBX18 B9D2 TGIF1 TGM1 MSH6 USP8 MFSD2A KLLN GTF2I DCLRE1C SMC3 INF2 IL12A-AS1 BTNL2 SCARB2 PPP1R15B PAFAH1B1 TLR4 SLC49A4 PRDX1 PAH FIBP HAAO WDR73 CD151 HABP2 PAX1 PAX2 PAX4 PAX6 SEC63 PBX1 BUB3 KAT6B HBB PC RNF139 CDC42 TNXB DISP1 PCK1 PCK2 TP53 COX14 CDK4 CDK6 LARGE1 PIGY CDKN1B CFH CDKN1C PIGN H19-ICR HGD TMEM67 TREX1 ASXL1 POU6F2 HIC1 PDE6D GCM2 CEL HLA-B MICOS13 MNX1 CENPF PDGFRB LEMD3 HLA-DPA1 HLA-DPB1 ENPP1 HLA-DRB1 SLC26A4 CD2AP CFTR TRPC6 GDF6 COPB2 PEX1 CLEC7A PEX6 PEX7 DNAJC21 PEX10 HMBS SOX18 PEX12 PEX13 PEX14 KCNE5 HPSE2 TSC1 TSC2 CHD4 WNT4 HMOX1 CHN1 HNF4A TRIP13 PGAM2 TRIP11 CHRM3 TTR PGK1 ALX4 PGM3 HNRNPU HIRA RNU4ATAC SNAP29 PHEX ERCC8 HOXA13 COLEC11 PHYH SERPINA1 AP2S1 SLC9A3R1 DMRT3 PIGA CLCN5 CLCNKA GRHPR CLCNKB COG1 HOXD13 PIK3CA ANLN PIK3R2 SHPK DSTYK HS6ST1 HPRT1 RAB3GAP2 RECQL4 HPS1 UFD1 PKD1 PKD2 PEX16 HRAS ASPM PKHD1 UMOD LMOD1 ALG8 UMPS PLAGL1 COL14A1 CCR1 CCR6 PLCD1 IL17RA FLRT3 PLD1 PLEC PLG HSD17B4 PYCR2 SERPINF2 TMCO1 SEC61A1 EIF2AK3 KDM6A NIPBL HSPA9 PML COL1A1 PMM2 VDR COL3A1 COL4A1 POMT2 PROK2 VHL COL4A3 COL4A4 COL4A5 COL5A1 COL5A2 HSPG2 COL7A1 PIGL WAS SLC2A9 COMT WIPF1 TAPT1 ADAMTS3 CLIP2 DLL4 FKRP WFS1 NSD2 NELFA INPP5E IARS WNT3 POLE WNT5A RRM2B SMARCAL1 EFEMP2 LZTFL1 NDUFAF3 COX6B1 WRN WT1 COX8A POR COX10 PORCN XDH POU3F4 MINPP1 SLC34A3 NABP1 PPARG XRCC2 CPT1A XRCC4 CPT2 GABBR2 GTF2IRD1 CFI GDF3 KANK2 CREBBP YWHAE PREPL SHANK3 ZAP70 SH2B1 SLC22A12 MMACHC PPM1B ZIC2 ZIC3 THOC6 IGF2 PPP3CA NSMF KANSL1 SEC24C ZNF592 PRCC NEK8 TTC37 SETBP1 IQCB1 ATP6V0A4 SLC6A20 CEP135 LPIN2 CEP41 GEMIN4 PRKAR1A CYP4F22 APPL1 PRKCD CCN2 CTH CAVIN1 CTLA4 PRKCSH NUP93 CTNS CTNNB1 MAP2K1 IL17RD MAP2K2 FAM20A CEP57 IL2RG IL7R CRB2 PRODH SEMA3E CYB561 PRPS1 IL10 COX20 LDLRAP1 IL12A TCTN3 IFT140 MASP1 DDX59 AHI1 ZBTB16 PRTN3 PLVAP ZNF148 HDAC4 TRAF3IP1 TMEM237 ABCA12 PET100 INS IFT172 CYP24A1 INSL3 CYP27A1 KIAA0586 VPS33A PDX1 ITGA6 PTPN22 IRF5 CFHR5 KCTD1 KEAP1 ITGA2 ITGA2B ITGA3 DCC PTCH1 PTEN BCOR ACE NPHP4 NSUN2 ITGB3 ITGB4 ZEB2 PTH1R MRPS22 PHGDH SLC36A2 MKS1 HELLPAR KIAA0753 FBXL4 TBC1D20 NSDHL BSND LRIG2 TMEM260 MAGI2 FREM2 FAM20C ANOS1 NPHS2 PTPN11 ARL6IP6 SARS2 CEP120 ALMS1 PROKR2 CLPB VPS33B SDHAF2 FIG4 PTPRO WASHC5 FGF20 KCNH1 KCNJ1 KCNJ5 DHCR7 DHCR24 KCNJ10 KCNJ11 TMEM70 ARNT2 DHODH PEX19 PEX2 PEX5 DKC1 KIF14 KCNQ1 ALDH18A1 FIP1L1 PYGM MAFB RBM8A CDC73 AMMECR1 RMND1 DMP1 TMEM231 CPLANE1 DNA2 HYMAI DNASE1L3 IL23R JAM3 WDR62 PCSK9 CDON MOCOS KNL1 RAD21 FOXP3 RAD51 TBX22 RAD51C KRAS RAF1 RAG1 RPGRIP1 DPH1 RAG2 SCO2 AKT3 FAT4 RAP1A PDSS2 RAP1B EVC2 B3GLCT RARA RARB KRT17 MCPH1 WDR34 NUP107 DYNC2H1 COG7 RBBP8 DUSP6 TPRKB KAT6A COQ6 DVL1 DVL3 GLIS3 AGGF1 WDR60 LAMB2 SALL4 FANCL REN DPF2 REST LCAT RET RFC2 DLL1 CCNQ LDHA PQBP1 AAGAB TBL1XR1 LDLR JMJD1C WDPCP PALB2 LETM1 NARS2 NLRP3 EDNRB PHC1 RFWD3 KIF7 BBS10 CEP55 ESCO2 SLC17A5 LHX1 RMRP RASGRP1 MLXIPL LIG4 LIMK1 KMT2D TRNT1 HMGA2 LMNA ADGRG2 SETD5 LMX1B TRIM28 BBS7 VANGL1 CCBE1 SBDS FANCI ARID2 ALG9 ARMC5 SPRY4 CEP83 TTC21B MED25 LRP2 EHMT1 LRP4 SASS6 LRP5 ROBO2 UBAC2 CAMKMT ALOXE3 YY1AP1 BSCL2 ELN CLDN19 C8ORF37 EMP2 LYZ ENG CSPP1 TBL2 CD96 EP300 COQ7 RPL11 SMAD4 TCTN2 PLCE1
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
Nephropathy
Genes 94
WDR19 BLK COL4A1 NPHP1 TMEM67 TREX1 KLF11 COL7A1 IFT140 HNF1A SAA1 HIC1 MYH9 VIPAS39 NEUROD1 RPGRIP1L CEP120 GLA WAS CEL WIPF1 WDR4 WDR34 NUP107 VPS33B TMEM237 CISD2 DYNC2LI1 LMX1B DYNC2H1 WFS1 INS INPP5E IFT172 FOS ABCC8 ZNF423 SLC26A4 SCARB2 KCNJ10 B2M KCNJ11 PAFAH1B1 CEP290 TPRKB TMEM216 AGPAT2 PRDX1 TTC21B SCNN1A SCNN1B NUP133 WT1 FGA PDX1 TMEM138 SCNN1G WDR60 CC2D2A UMOD APPL1 LAGE3 APOA1 MAFB WDR73 CD151 CCND1 CAVIN1 BSCL2 GCK PAX4 CLDN19 IFT80 PAX6 CAV1 TP53RK PPARG OSGEP TMEM231 HNF4A LYZ FAM20A SEC61A1 ADA2 EIF2AK3 YWHAE TTR MEFV ALG1 NLRP3 MMACHC PRODH FOXI1 NOD2