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Report for Clinical Trial NCT02175966

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study)

The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

NCT02175966 Hepatitis C
MeSH: Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO: Hepatitis

4 Interventions

Name: DCV/ASV/BMS-791325

Type: Drug

Arm 1: DCV/ASV/BMS-791325+Sofosbuvir Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a

Name: Ribavirin

Type: Drug

Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a

Name: Sofosbuvir

Type: Drug

Arm 1: DCV/ASV/BMS-791325+Sofosbuvir Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a

Name: Peginterferon α-2a

Type: Drug

Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a


Primary Outcomes

Description: SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach.

Measure: Percentage of Participants With Sustained Virologic Response 12 (SVR12)

Time: 12 Weeks after treatment discontinuation (Follow-up Week 12)

Description: SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.

Measure: Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment

Time: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)

Description: Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.

Measure: Number of Participants With Selected Grade 3/4 Laboratory Abnormalities

Time: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)

Secondary Outcomes

Description: EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.

Measure: Percentage of Participants With End of Treatment Response (EOTR)

Time: End of the treatment

Description: Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24).

Measure: Percentage of Participants Who Achieved HCV RNA Time: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)

Description: Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24).

Measure: Percentage of Participants Who Achieved HCV RNA < LLOQ TND

Time: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24

Description: Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b

Measure: Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b

Time: Post-treatment Week 12

Description: Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.

Measure: Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)

Time: Post-treatment Week 12

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype).

Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported..



HPO Nodes


HPO:
Hepatitis
Genes 90
CD247 CTNNB1 ATP7B CASP10 PIEZO1 GUSB BLNK SHPK CYP7A1 IL17RA IGF2R CASP8 SH2D1A SLC25A15 BTK BTK C4B CD79B VPS33B XIAP SERPINA1 PIK3R1 GLIS3 POU2AF1 CIITA FOXP3 TPP2 RFX5 CIITA RASGRP1 RFXANK SLC25A15 AXIN1 TCF4 CD3D TP53 IL12A PRKCD CD40LG BTK IGHM IL17RC ALMS1 TRAF3IP2 KRT8 FAS LRRC8A FAS IL17F XIAP SPIB C1S RFX5 RFXAP MST1 TTC7A COG8 SKIV2L VIPAS39 IGLL1 PDGFRL TNFSF15 HSD3B7 CD3E AMACR ATP7B FASLG RFXANK IL12RB1 TCF3 CD79A KRT18 IRF5 MET PIK3CA MMEL1 ITCH TBX19 IL21R AIRE RFXAP TTC7A CLEC7A GPR35 ATP7A CYP7B1 STAT1 PGM1 APC TNPO3