SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02175966

Developed by Shray Alag, 2019.
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 Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic
HPO: Chronic active hepatitis Chronic hepatitis 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:
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