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Report for Clinical Trial NCT02580474

Developed by Shray Alag, 2020.
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 445
DZIP1L CLPB HNF1B TMEM67 NUP160 AGPAT2 LZTFL1 LAGE3 PLCE1 SDCCAG8 HMBS PKD1 SALL1 RASGRP1 WT1 SCNN1B CEP290 BICC1 PRKCD NUP85 TMEM231 NPHP4 CLCNKB RPGRIP1L KYNU IFT172 ERCC4 NPHP3 REN OCRL TTC21B FN1 HSD11B2 WDR73 TPRKB WDR19 PAX6 TBC1D8B SPRY2 FANCF PNPLA6 ALOX12B LAMB2 TBX18 SCNN1G PAX2 SCNN1B NPHP4 TRNL1 TMEM67 CFH SIX5 MYO1E WT1 MLXIPL CFHR5 CLIP2 GLIS2 TRNF CLCN5 SH2B1 AGXT CEP290 PGK1 LHX1 HLA-DPB1 WT1 IFT172 IL10 LEMD3 TMEM216 TBL2 AMMECR1 ALMS1 NPHP3 WDR73 IL12A-AS1 FAH MST1 CFH TMEM237 FANCG CCND1 TCN2 DSTYK HPRT1 IFT27 SULT2B1 NUP205 COQ8B PGAM2 ND5 CD151 SDR9C7 SLC26A1 HPRT1 SLC7A7 GTF2I IFT122 APRT SHPK CLCN5 KIAA0586 RPGRIP1L TRNH CORIN NUP107 FOS MAFB CYP4F22 TRNL1 HBB MEN1 CCR6 CAV1 STS XPNPEP3 ERCC4 FANCB KMT2A RAD51 RMND1 C1R MMUT OCRL FANCD2 TRNE OSGEP UMOD LCAT TRPC6 NPHP1 CCNQ CHD4 SDCCAG8 CRB2 PKHD1 BRCA1 SIX1 SPP1 TRNS1 WT1 NEK8 INVS KCTD1 XRCC2 KCNE5 LRIG2 GATA3 ANKS6 CCN2 NIPBL TMEM231 GRHPR CPT2 COL4A1 PTPN22 COX1 BBS10 SAA1 HPRT1 CLDN10 WDR60 LMX1B TMEM237 CLDN19 FANCL CLCNKA TRNW COX3 NUP93 C1QA CDC73 INVS KLRC4 ITGA3 CFI RAD51C HLA-B DNAJB11 DGKE COX2 GRHPR FAS IFT140 GSN BTNL2 IFT80 DYNC2H1 GLA FLT1 FASLG PAX2 IFT43 CDC73 SLC7A9 TTC21B PRTN3 ABCC6 PPARG XYLT1 FXYD2 RAD51C NLRP3 C3 MME PRDX1 COL7A1 PHYH NPHP1 ERCC6 TMEM67 CCR1 BAZ1B NPHP4 SLC34A1 NUP133 ND4 STOX1 RFWD3 INF2 FAM20A RFC2 FAM20A IQCB1 DACT1 COL4A1 TRNT APRT ARHGDIA HLA-B SEC61A1 CPT2 GSN HNF1B AQP2 TRNQ CLCN5 GTF2IRD1 STAT4 MEFV ABCA12 SCARB2 SMC3 FANCI FN1 CC2D2A RPGRIP1L CACNA1S CFB IFT140 GATA3 XYLT2 BSCL2 VANGL1 MAPKBP1 CPT2 MAD2L2 AP2S1 HELLPAR PEX7 SLC3A1 C3 CFH SETD5 TRNK IRF5 UMOD GPR35 FANCA CTNS MUC1 COL4A4 HLA-DPA1 TP53RK SLX4 CASP10 ALDOB MYD88 GLA NOTCH2 CEP290 JAG1 FAN1 CLCN5 TSC1 BSND CC2D2A SIX5 EIF2AK3 SCNN1A CEP83 CLDN16 ELN SMARCAL1 WDR34 CAVIN1 LMX1B BNC2 LAMB2 PALB2 CFI PKD2 AMMECR1 CD46 FANCE ZNF592 FANCM TMEM67 NPHP1 HLA-DRB1 ZNF423 CFI LMX1B TRAF3IP1 HNF1B CEP120 LPIN1 HDAC8 ELN IL12A IL23R LRIG2 DNASE1L3 ND6 SLC37A4 DZIP1L LIPN COG1 ACSL4 SLC22A12 MOCOS CEP164 HNF4A EIF2AK3 TMEM138 CC2D2A CFHR1 TMEM67 SOX18 TGM1 APOE PTPN22 UMOD ALOXE3 SGPL1 RYR1 DHDDS SLC30A9 FUZ CTNS WDR35 NPHP3 HPSE2 TSC2 NUP107 OFD1 OCLN EHMT1 ERAP1 COL4A3 INPP5E CD2AP ANLN PAX2 GCM2 PYGM WDR19 EYA1 FAS DCDC2 TRNS2 CEP290 COL4A5 NOD2 APOL1 LDHA NPHS1 TMEM260 THBD CAV1 ALMS1 HPS1 CHRM3 LIMK1 CTLA4 DYNC2LI1 CFHR3 AVPR2 BBIP1 BRCA2 FAS WDR19 SMC1A AGXT PGK1 PBX1 HLA-DRB1 TLR4 STAT4 IKZF1 MYH9 TMEM126B RAD21 CDC73 MAGI2 ND1 TTC21B AHI1 OCRL TRAF3IP1 NPHS2 NPHP3 WT1 COL4A3 TCF4 ELP1 NPHP1 WDR19 CD46 UBAC2 WDR19 ACTN4 C4A HRAS PRPS1 IRAK1 IQCB1 MMUT NPHP1 FANCC SALL1 NIPAL4 BRIP1 MEFV PKHD1 MEFV SARS2 ERCC8 MMACHC CPT2 CSPP1 MMUT UBE2T HOXA13