SNPMiner Trials (Home Page)
Report for Mutation H275Y
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 A Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Investigational Intravenous Peramivir in Children With Influenza Disease (CASG 117)
The purposes of this study are to evaluate the pharmacokinetics (affect the body has on a drug), and pharmacodynamics (affect the drug has on the body) and safety of an experimental intravenous (within a vein) flu medication, peramivir, in children. Participants will include 63 hospitalized children with confirmed flu. Children will be grouped according to age and younger children will not receive drug until safety data from the groups of older children are reviewed. Hospitalized children may receive up to 5 doses of peramivir. Study procedures include: nasal/throat swabs, reporting any experienced side effects, physical examination including assessment of the nervous system, and blood sample collection. Participants will be involved in study related procedures for up to 28 days.
NCT01063933 Influenza Drug: Peramivir MeSH:Influenza, Human
-Documented H275Y mutation (note: it is unlikely that resistance testing will have been completed for most subjects). --- H275Y ---
Primary Outcomes
Measure: Peramivir dose that provides area under the curve (AUC)24 between 60 microgram (mcg) hour(hr)/liter (L) and 94 mcg hr/L. Time: Within 15 minutes prior to dosing, and at the following timepoints measured from the time of the start of the infusion: 1-1.25 hours (end of infusion), 2-3 hours, 5-7 hours, 10-12 hours, and 22-24 hours post-dosing.Measure: Pharmacokinetic parameters for peramivir, including AUC24, maximum serum concentration (Cmax), half-life (T1/2), Clearance (CL), and time to maximum concentration (Tmax). Time: Within 15 minutes prior to dosing, and at the following timepoints measured from the time of the start of the infusion: 1-1.25 hours (end of infusion), 2-3 hours, 5-7 hours, 10-12 hours, and 22-24 hours post-dosing.
Secondary Outcomes
Measure: Safety: overall incidence of adverse events. Time: Day 1 to Day 28Measure: Safety: the incidence of grade 3-4 adverse events or severe adverse events. Time: Day 1 to Day 28
Measure: Safety: the incidence of adverse events considered to be related to study treatment. Time: Day 1 to Day 28
Measure: Safety: the incidence of adverse events leading to discontinuation of study drug. Time: Day 1 to Day 28
Measure: Virologic: proportion of subjects who are negative for viral ribonucleic acid (RNA) by reverse transcriptase-polymerase chain reaction (PCR). Time: Day 3, 5, and 10.
Measure: Virologic: incidence of treatment emergent peramivir resistant virus. Time: Study days 1, 3, 5, and 10.
Measure: Virologic: time to no detectable viral ribonucleic acid (RNA) by polymerase chain reaction (PCR). Time: Study days 1, 3, 5, and 10.
Measure: Virologic: quantitative viral load over time. Time: Study days 1, 3, 5, and 10.
Measure: Safety: the incidence of severe or grade 3 and 4 treatment related adverse events. Time: Day 1 to Day 28
Measure: Safety: the incidence of treatment-related serious adverse events. Time: Day 1 to Day 28
Measure: Safety: the incidence of serious adverse events and deaths. Time: Day 1 to Day 28
2 Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission
This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.
NCT02786381 Respiratory Tract Infections Influenza, Human Respiratory Syncytial Virus Infections MeSH:Infection Communicable Diseases Respiratory Tract Infections Respiratory Syncytial Virus Infections Influenza, Human
HPO:Respiratory tract infection
The IFV-RSV Panel is an in vitro PCR-based molecular diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A (including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal swabs (NP) in viral transport media (VTM) in adults, adolescents, and children. --- H275Y ---
Primary Outcomes
Description: Product Performance will be assessed based on samples collected in 2015/2016 season (average of 6 months) and archived samples.
Measure: Product performance as measured by positive and negative agreement to a predicate Time: Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 months.