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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
Group Labels: 1

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

Allocation: N/A

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:
HP:0000083: Renal insufficiency
Genes 446
OCRL CSPP1 CLDN10 COQ8B SIX1 KCTD1 SCNN1A CPT2 TCF4 CFI FXYD2 BSCL2 MUC1 HNF1B NUP85 IL12A FASLG ERCC6 TRNL1 STOX1 SETD5 OCRL PKD2 IRAK1 CLCN5 MST1 TRNL1 STS IL12A-AS1 ERAP1 CFI DNASE1L3 HDAC8 WT1 CFH ND1 PGK1 KMT2A WDR19 NEK8 COX2 NIPAL4 MEN1 EIF2AK3 SCNN1B UMOD SDCCAG8 CORIN CFH HPRT1 FAN1 XRCC2 FOS PGK1 PLCE1 COL4A4 HELLPAR NPHP4 TRNQ REN SGPL1 HOXA13 CD46 PALB2 CC2D2A RPGRIP1L GLIS2 TMEM126B TMEM67 MEFV FANCE MAPKBP1 INPP5E RMND1 TMEM216 ANLN HLA-DRB1 TRNS1 RAD51 ALMS1 TSC1 CD2AP TMEM67 NUP205 APRT DHDDS CRB2 SMC1A C1R HPSE2 NPHP3 TP53RK FANCD2 HLA-DRB1 GLA OCRL TMEM67 AVPR2 IFT122 WDR73 ERCC4 DYNC2H1 AGXT HLA-DPA1 STAT4 PAX2 GLA MAFB NUP133 FAM20A LEMD3 APOE ABCA12 FLT1 FN1 ACSL4 ERCC4 MME FN1 CFB LIPN UMOD IFT140 MMACHC TTC21B CTNS SULT2B1 KCNE5 BRCA1 IFT80 RFWD3 COX1 HPS1 WDR19 ELN COL7A1 WDR73 ACTN4 ND5 CPT2 ND4 ANKS6 LRIG2 MOCOS NPHP1 ZNF423 NUP107 HMBS CAV1 PTPN22 RPGRIP1L MMUT C1QA ELN PAX6 MMUT LMX1B RYR1 RPGRIP1L AP2S1 CCR6 CCN2 LMX1B FANCC APOL1 MEFV CD46 CCR1 MAD2L2 TMEM237 BICC1 MAGI2 MMUT AMMECR1 CLCN5 AHI1 CFHR5 SARS2 PAX2 RFC2 RAD51C CLDN19 GSN NPHS2 CLCNKB ZNF592 SCNN1B CCNQ WT1 TBX18 ND6 CTLA4 PRTN3 SCNN1G TRNT MEFV LCAT SIX5 GRHPR C3 XYLT1 HNF1B TTC21B XYLT2 MYH9 SOX18 KYNU MYO1E TRNF IFT140 APRT CLCN5 BNC2 SMC3 IQCB1 KLRC4 IFT172 COL4A5 TCN2 PKHD1 AGPAT2 LPIN1 HBB CC2D2A PRDX1 IQCB1 IFT27 LIMK1 CHRM3 LHX1 DGKE TBL2 PAX2 UBE2T CLDN16 WDR19 CEP164 PNPLA6 SDR9C7 CEP290 TMEM67 GATA3 AQP2 NPHP1 SLC26A1 CEP290 SHPK SMARCAL1 INF2 KIAA0586 FUZ FAH SLC22A12 GSN FANCL NPHP1 OCLN OFD1 DCDC2 DZIP1L XPNPEP3 SLC7A9 BBS10 CEP83 SH2B1 LAGE3 C3 SPRY2 INVS RAD21 NPHP1 NOD2 CLIP2 ERCC8 BRIP1 WT1 HSD11B2 CHD4 NPHP3 NIPBL FANCF COL4A1 CLCN5 FAS ARHGDIA CACNA1S HLA-B NUP160 CTNS IFT172 DACT1 SLC30A9 HLA-DPB1 SDCCAG8 CEP120 WT1 UMOD EHMT1 TMEM138 EIF2AK3 LDHA EYA1 CFI ALDOB TMEM260 C4A CAV1 UBAC2 INVS PTPN22 TRNK TMEM67 TRPC6 WDR19 PBX1 IL23R CPT2 LMX1B TTC21B WDR35 ITGA3 PEX7 CEP290 COG1 WDR60 FANCA SIX5 CD151 TMEM237 SEC61A1 PKD1 CC2D2A PKHD1 HNF1B FANCM TMEM231 NOTCH2 DZIP1L SLC7A7 TLR4 SLC3A1 CYP4F22 ALOXE3 AMMECR1 SAA1 CDC73 HPRT1 IL10 ALOX12B DSTYK ALMS1 PUS3 RASGRP1 TSC2 BSND BBIP1 CASP10 BRCA2 NPHP4 DYNC2LI1 STAT4 TPRKB NPHS1 RAD51C HLA-B CDC73 GTF2I TRNW COX3 SLC37A4 COL4A1 HNF4A MYD88 JAG1 BTNL2 TRAF3IP1 SLX4 TRNH IKZF1 PYGM DNAJB11 LZTFL1 NUP107 CLCNKA CFHR1 NUP93 GPR35 PRKCD LRIG2 COL4A3 FAM20A GRHPR TRNS2 PRPS1 MLXIPL HRAS NPHP1 FANCG FANCI SLC34A1 TRAF3IP1 SCARB2 CFHR3 TGM1 NLRP3 PGAM2 CAVIN1 GCM2 PPARG ELP1 BAZ1B NPHP3 CDC73 IRF5 FAS NPHP4 ABCC6 GATA3 FANCB WDR34 COL4A3 SPP1 OSGEP NPHP3 TRNE CCND1 HPRT1 SALL1 LAMB2 IFT43 FAS WDR19 CFH SALL1 CEP290 TMEM231 CLPB CPT2 WT1 AGXT TBC1D8B GTF2IRD1 VANGL1 LAMB2 THBD PHYH
Protein Mutations 2
L31F Y93H
SNP 0