SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02580474

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.

NCT02580474 Hepatitis C
MeSH: Hepatitis C Renal Insufficiency Kidney Failure, Chronic
HPO: Renal insufficiency

1 Interventions

Name: Daclatasvir plus Asunaprevir

Type: Drug

Daclatasvir plus Asunaprevir


Primary Outcomes

Measure: the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment

Time: 36 Week

Secondary Outcomes

Measure: To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment

Time: 36 Week

Measure: Percentage of subjects with ALT normalization at each visit from the baseline

Time: 4, 12, 24, 36 week

Measure: Change in HCV RNA at each visit from the baseline

Time: 4, 12, 24, 36 week

Measure: Percentage of subjects who experience viral breakthrough at each visit from the baseline

Time: 4, 12, 24, 36 week

Measure: Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from

Time: 4, 12, 24, 36 week

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 L31F

Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening - No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H Exclusion Criteria: - A patient who having received Daclatasvir or Asunaprevir - Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study - Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV - Diagnosed or suspected hepatocellular carcinoma or other malignancies - Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage) - Received solid organ or bone marrow transplant - Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance - Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator - Known hypersensitivity to study drugs, metabolites, or formulation excipients - Who has taken investigational drugs within 2 months. --- L31F ---


2 Y93H

Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening - No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H Exclusion Criteria: - A patient who having received Daclatasvir or Asunaprevir - Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study - Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV - Diagnosed or suspected hepatocellular carcinoma or other malignancies - Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage) - Received solid organ or bone marrow transplant - Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance - Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator - Known hypersensitivity to study drugs, metabolites, or formulation excipients - Who has taken investigational drugs within 2 months. --- L31F --- --- Y93H ---



HPO Nodes


HPO:
Renal insufficiency
Genes 322
IL10 CFH MYD88 IL12A TMEM67 IFT140 DNAJB11 MYH9 ANKS6 AHI1 BRIP1 ERCC4 PRTN3 ERCC6 GCM2 NUP85 TRAF3IP1 HLA-B MYO1E TMEM237 ERAP1 LEMD3 HLA-DPA1 AVPR2 ABCA12 HLA-DPB1 IFT172 ZNF423 SMC1A HLA-DRB1 SDCCAG8 DZIP1L TMEM126B CD2AP TRPC6 KIAA0586 TMEM216 HDAC8 COQ8B GATA3 PEX7 HMBS SOX18 DHDDS LAGE3 KCNE5 PTPN22 HPSE2 IRF5 IKZF1 TSC1 ACTN4 TSC2 CCND1 CD46 CHD4 CFHR5 KCTD1 EYA1 ITGA3 HNF4A NPHP4 PGAM2 CHRM3 SLC26A1 KLRC4 PGK1 IFT43 MEFV RYR1 STAT4 HELLPAR MEN1 NUP205 FANCA NOD2 FANCC FANCD2 BSND FANCE LRIG2 TMEM260 ACSL4 MAGI2 LPIN1 FAH ERCC8 HOXA13 FANCB DACT1 FANCF FANCG PHYH SAA1 NPHS2 AP2S1 SARS2 CEP120 SALL1 PNPLA6 GLA BRCA1 CLCN5 ALMS1 BRCA2 CLCNKA CLPB GRHPR CLCNKB SULT2B1 COG1 ANLN SGPL1 SHPK DSTYK HPRT1 JAG1 GLIS2 HPS1 AGXT PKD1 PKD2 HRAS SCNN1A PKHD1 SCNN1B WDR35 SCNN1G CC2D2A KMT2A UMOD PYGM C3 CCR1 MAFB C4A CCR6 IFT80 CDC73 MAD2L2 TP53RK AMMECR1 RMND1 TMEM231 SLC30A9 ALDOB SEC61A1 EIF2AK3 NIPBL KYNU NUP160 DNASE1L3 ALOX12B IL23R NOTCH2 MOCOS RAD21 RAD51 RAD51C COL4A1 NPHP1 NPHS1 COL4A3 COL4A4 COL4A5 CACNA1S IFT27 TCF4 COL7A1 NIPAL4 HNF1B DCDC2 RPGRIP1L FN1 OFD1 WDR34 NUP107 TCN2 CLIP2 DYNC2H1 GPR35 INPP5E FOS SMARCAL1 LZTFL1 CEP290 TPRKB AGPAT2 WT1 BBIP1 TMEM138 ELP1 FUZ BAZ1B WDR60 LAMB2 CASP10 DGKE FANCL LIPN REN OCRL CAV1 LCAT APOE PPARG OSGEP XRCC2 RFC2 SIX1 SLC7A7 CPT2 FANCM APRT GTF2IRD1 CFI FAS CCNQ LDHA FASLG AQP2 CLDN10 ABCC6 PALB2 CEP164 SH2B1 SLC22A12 NLRP3 MMACHC GSN RFWD3 SLC3A1 BBS10 FAN1 SDR9C7 WDR19 SLC7A9 MST1 LHX1 TBX18 TGM1 ARHGDIA RASGRP1 MLXIPL LIMK1 NPHP3 GTF2I STS COX1 COX2 UBE2T COX3 SMC3 INF2 ZNF592 SETD5 SLC34A1 DYNC2LI1 LMX1B IL12A-AS1 VANGL1 FANCI NEK8 BTNL2 SCARB2 ND1 IQCB1 XPNPEP3 ND4 TLR4 ND5 PRDX1 ND6 CEP83 CLDN16 TTC21B NUP133 EHMT1 SIX5 CYP4F22 TRNE PRKCD UBAC2 TRNF WDR73 ALOXE3 CD151 CCN2 CAVIN1 BSCL2 TRNH PAX2 IFT122 CTLA4 ELN TRNK CLDN19 TRNL1 NUP93 PAX6 CTNS TRNQ MAPKBP1 TRNS1 TRNS2 PBX1 OCLN TRNT TRNW HBB FAM20A FXYD2 MUC1 CSPP1 SLC37A4 TBL2 SLX4 MMUT CRB2 INVS PLCE1 PRPS1