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Statements

Subject Item
n2:RIV%2F61989592%3A15120%2F13%3A33149366%21RIV15-MSM-15120___
rdf:type
n4:Vysledek skos:Concept
dcterms:description
Granulocyte colony-stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy. A previous phase IIa dose-escalation study suggested potential efficacy in humans. The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients. G-CSF (135 ?g/kg body weight intravenous over 72 hours) was tested against placebo in 328 patients in a multinational, multicenter, randomized, and placebo-controlled trial (NCT00927836; www.clinicaltrial.gov). Main inclusion criteria were ?9-hour time window after stroke onset, infarct localization in the middle cerebral artery territory, baseline National Institutes of Health Stroke Scale score range of 6 to 22, and baseline diffusion-weighted imaging lesion size ?15 mL. Primary and secondary end points were the modified Rankin scale score and the National Institutes of Health Stroke Scale score at day 90, respectively. Data were analyzed using a prespecified model that adjusted for age, National Institutes of Health Stroke Scale score at baseline, and initial infarct volume (diffusion-weighted imaging). G-CSF treatment failed to meet the primary and secondary end points of the trial. For additional end points such as mortality, Barthel index, or infarct size at day 30, G-CSF did not show efficacy either. There was, however, a trend for reduced infarct growth in the G-CSF group. G-CSF showed the expected peripheral pharmacokinetic and pharmacodynamic profiles, with a strong increase in leukocytes and monocytes. In parallel, the cytokine profile showed a significant decrease of interleukin-1. G-CSF, a novel and promising drug candidate with a comprehensive preclinical and clinical package, did not provide any significant benefit with respect to either clinical outcome or imaging biomarkers. Granulocyte colony-stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy. A previous phase IIa dose-escalation study suggested potential efficacy in humans. The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients. G-CSF (135 ?g/kg body weight intravenous over 72 hours) was tested against placebo in 328 patients in a multinational, multicenter, randomized, and placebo-controlled trial (NCT00927836; www.clinicaltrial.gov). Main inclusion criteria were ?9-hour time window after stroke onset, infarct localization in the middle cerebral artery territory, baseline National Institutes of Health Stroke Scale score range of 6 to 22, and baseline diffusion-weighted imaging lesion size ?15 mL. Primary and secondary end points were the modified Rankin scale score and the National Institutes of Health Stroke Scale score at day 90, respectively. Data were analyzed using a prespecified model that adjusted for age, National Institutes of Health Stroke Scale score at baseline, and initial infarct volume (diffusion-weighted imaging). G-CSF treatment failed to meet the primary and secondary end points of the trial. For additional end points such as mortality, Barthel index, or infarct size at day 30, G-CSF did not show efficacy either. There was, however, a trend for reduced infarct growth in the G-CSF group. G-CSF showed the expected peripheral pharmacokinetic and pharmacodynamic profiles, with a strong increase in leukocytes and monocytes. In parallel, the cytokine profile showed a significant decrease of interleukin-1. G-CSF, a novel and promising drug candidate with a comprehensive preclinical and clinical package, did not provide any significant benefit with respect to either clinical outcome or imaging biomarkers.
dcterms:title
Granulocyte colony-stimulating factor in patients with acute ischemic stroke: results of the AX200 for Ischemic Stroke trial Granulocyte colony-stimulating factor in patients with acute ischemic stroke: results of the AX200 for Ischemic Stroke trial
skos:prefLabel
Granulocyte colony-stimulating factor in patients with acute ischemic stroke: results of the AX200 for Ischemic Stroke trial Granulocyte colony-stimulating factor in patients with acute ischemic stroke: results of the AX200 for Ischemic Stroke trial
skos:notation
RIV/61989592:15120/13:33149366!RIV15-MSM-15120___
n5:aktivita
n14:S n14:I n14:N
n5:aktivity
I, N, S
n5:cisloPeriodika
10
n5:dodaniDat
n9:2015
n5:domaciTvurceVysledku
n15:3054691
n5:druhVysledku
n17:J
n5:duvernostUdaju
n12:S
n5:entitaPredkladatele
n8:predkladatel
n5:idSjednocenehoVysledku
76827
n5:idVysledku
RIV/61989592:15120/13:33149366
n5:jazykVysledku
n16:eng
n5:klicovaSlova
stroke; phase II; MRI; leukocytes; hematopoietic growth factor; G-CSF; clinical trial
n5:klicoveSlovo
n7:G-CSF n7:leukocytes n7:phase%20II n7:stroke n7:hematopoietic%20growth%20factor n7:MRI n7:clinical%20trial
n5:kodStatuVydavatele
US - Spojené státy americké
n5:kontrolniKodProRIV
[EDB87837F2A6]
n5:nazevZdroje
Stroke
n5:obor
n6:FP
n5:pocetDomacichTvurcuVysledku
1
n5:pocetTvurcuVysledku
11
n5:rokUplatneniVysledku
n9:2013
n5:svazekPeriodika
44
n5:tvurceVysledku
Thijs, Vincent Schneider, Armin Chamorro, Angel Rathgeb, Frank Saver, Jeff Aichner, Franz Laage, Rico Školoudík, David Grond, Martin Ringelstein, Erich Bernd Norrving, Bo
s:issn
0039-2499
s:numberOfPages
8
n11:doi
10.1161/STROKEAHA.113.001531
n18:organizacniJednotka
15120