SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01718158

Developed by Shray Alag, 2019.
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 Hepatitis C
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 Lambda-1a + Ribavirin + Daclatasvir Peginterferon Alfa-2a + Ribavirin + Telaprevir

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 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