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Report for Clinical Trial NCT01718158

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

NCT01718158 Hepatitis C
MeSH: Hepatitis C Hepatitis
HPO: Hepatitis

5 Interventions

Name: Peginterferon Lambda-1a

Type: Biological

Peginterferon Lambda-1a + Ribavirin + Daclatasvir

Name: Peginterferon Alfa-2a

Type: Biological

Peginterferon Alfa-2a + Ribavirin + Telaprevir

Name: Ribavirin

Type: Drug

Peginterferon Alfa-2a + Ribavirin + Telaprevir Peginterferon Lambda-1a + Ribavirin + Daclatasvir

Name: Daclatasvir

Type: Drug

Peginterferon Lambda-1a + Ribavirin + Daclatasvir

Name: Telaprevir

Type: Drug

Peginterferon Alfa-2a + Ribavirin + Telaprevir


Primary Outcomes

Measure: Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12)

Time: Post treatment follow-up Week 12

Secondary Outcomes

Measure: Proportion of subjects who achieve SVR12 in treatment-naive subjects

Time: Post treatment follow-up Week 12

Measure: Proportion of subjects with rash related dermatologic events

Time: Up to 12 weeks of treatment

Description: Treatment emergent cytopenic abnormalities [anemia as defined by Hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750/mm3, and or thrombocytopenia as defined by platelets < 50,000/mm3]

Measure: Proportion of subjects who develop treatment emergent cytopenic abnormalities

Time: Up to 48 Weeks

Measure: Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms

Time: Up to 48 Weeks

Description: SVR24 = Sustained virologic response at post treatment follow-up Week 24

Measure: Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24

Time: Post treatment follow-up Week 24

Measure: Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up

Time: Maximum of 72 weeks

Measure: Proportion of subjects who achieve SVR12 with a 24-week treatment regimen

Time: Post treatment follow-up Week 12

Measure: Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment)

Time: Weeks 4 and 12 of treatment

Measure: Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up

Time: Maximum of 72 weeks

Measure: Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT)

Time: Maximum of 72 weeks

Description: Psychiatric symptoms (depression, irritability or insomnia)

Measure: Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT

Time: Maximum of 48 weeks

Description: For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen

Measure: Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses

Time: Post-treatment follow-up Week 12

Measure: Resistant variants associated with virologic failure through end of follow-up

Time: Maximum of 72 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses.



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