Filgrastim(Axaron Bioscience)(Filgrastim(Axaron Bioscience)) - 药物靶点：CSF-3R_专利_临床

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

靶点

CSF-3R

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

神经系统疾病心血管疾病

在研适应症-

非在研适应症

急性缺血性卒中

原研机构

Axaron Bioscience AG

在研机构-

非在研机构

Sygnis Bioscience GmbH & Co KGAxaron Bioscience AG

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 4190

当前序列信息引自: *****

关联

4

项与 Filgrastim(Axaron Bioscience) 相关的临床试验

EUCTR2008-006444-19-SK / Not yet recruiting临床2期

AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trial

开始日期2009-08-13

申办/合作机构

Sygnis Bioscience GmbH & Co KG

NCT00927836 / Completed临床2期

AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial

The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of acute ischemic stroke and to assess the safety and tolerability of AX200.

开始日期2009-05-01

申办/合作机构

Sygnis Bioscience GmbH & Co KG

NCT00132470 / Completed临床2期

AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.

开始日期2004-12-01

申办/合作机构

Axaron Bioscience AG

100 项与 Filgrastim(Axaron Bioscience) 相关的临床结果

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100 项与 Filgrastim(Axaron Bioscience) 相关的转化医学

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100 项与 Filgrastim(Axaron Bioscience) 相关的专利（医药）

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8

项与 Filgrastim(Axaron Bioscience) 相关的文献（医药）

2021-03-01·Stroke1区 · 医学

Imaging Markers of Brain Frailty and Outcome in Patients With Acute Ischemic Stroke

1区 · 医学

Article

作者: Grond, Martin ; Norrving, Bo ; Thijs, Vincent ; Wilms, Guido ; Ringelstein, E. Bernd ; Lemmens, Robin ; Fiebach, Jochen B. ; Laage, Rico ; Chamorro, Angel ; Bu, Ning ; Khlif, Mohamed Salah ; Wouters, Anke ; Brodtmann, Amy

Background and Purpose:Functional outcome after stroke may be related to preexisting brain health. Several imaging markers of brain frailty have been described including brain atrophy and markers of small vessel disease. We investigated the association of these imaging markers with functional outcome after acute ischemic stroke.Methods:We retrospectively studied patients with acute ischemic stroke enrolled in the AXIS-2 trial (AX200 in Ischemic Stroke Trial), a randomized controlled clinical trial of granulocyte colony-stimulating factor versus placebo. We assessed the ratio of brain parenchymal volume to total intracerebral volumes (ie, the brain parenchymal fraction) and total brain volumes from routine baseline magnetic resonance imaging data obtained within 9 hours of symptom onset using the unified segmentation algorithm in SPM12. Enlarged perivascular spaces, white matter hyperintensities, lacunes, as well as a small vessel disease burden, were rated visually. Functional outcomes (modified Rankin Scale score) at day 90 were determined. Logistic regression was used to test associations between brain imaging features and functional outcomes.Results:We enrolled 259 patients with a mean age of 69±12 years and 46 % were female. Increased brain parenchymal fraction was associated with higher odds of excellent outcome (odds ratio per percent increase, 1.078 [95% CI, 1.008–1.153]). Total brain volumes and small vessel disease burden were not associated with functional outcome. An interaction between brain parenchymal fraction and large vessel occlusion on excellent outcome was not observed.Conclusions:Global brain health, as assessed by brain parenchymal fraction on magnetic resonance imaging, is associated with excellent functional outcome after ischemic stroke.Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00927836.

2016-03-14·The Medical letter on drugs and therapeutics4区 · 医学

Zarxio--a filgrastim biosimilar.

4区 · 医学

Review

2015-10-01·Journal of Cerebral Blood Flow & Metabolism2区 · 医学

Association between the Perfusion/Diffusion and Diffusion/FLAIR Mismatch: Data from the AXIS2 Trial

2区 · 医学

Article

作者: Laage, Rico ; Dupont, Patrick ; Chamorro, Angel ; Wouters, Anke ; Schneider, Armin ; Thomalla, Götz ; Ringelstein, Erich B ; Lemmens, Robin ; Thijs, Vincent N ; Wilms, Guido ; Grond, Martin ; Norrving, Bo

The perfusion-/diffusion-weighted imaging (PWI/DWI) mismatch and the diffusion/fluid attenuated inversion recovery (DWI/FLAIR) mismatch are magnetic resonance imaging (MRI) markers of evolving brain ischemia. We examined whether the DWI/FLAIR mismatch was independently associated with the PWI/DWI mismatch. Furthermore, we determined whether the presence of the DWI/FLAIR mismatch in patients with the PWI/DWI mismatch would provide additional information regarding last seen normal time (LTM). We used data from the ‘AX200 for ischemic stroke’ trial (AXIS 2 study NCT00927836). We studied the association between the presence of the DWI/FLAIR and PWI/DWI mismatch, baseline National Institute of Health Stroke Scale (NIHSS), age, ischemic-core volume, gender, intravenous (IV) tissue plasminogen activator (tPA), and perfusion-mismatch volume in univariate analysis. Significant variables ( P < 0.05) were added into the final multivariate model. We analyzed 197 patients. Seventy-two (37%) had both the PWI/DWI and the DWI/FLAIR mismatch. Patients with the double mismatch pattern had a shorter LTM than patients with the PWI/DWI mismatch alone (Median difference 90 minutes, P < 0.01). Multivariate analysis confirmed the independent association between the two mismatch patterns (odds ratio (OR) 2.6, 95% confidence interval (CI) 1.2 to 5.4). Our study implies that the DWI/FLAIR mismatch and PWI/DWI mismatch are strongly associated, independent from LTM. Furthermore, in the presence of the PWI/DWI mismatch, the DWI/FLAIR pattern indicates a shorter LTM. This could have implications in selecting patients for reperfusion therapy.

100 项与 Filgrastim(Axaron Bioscience) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性缺血性卒中	临床2期	德国	Axaron Bioscience AG	2004-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO_ASIA2022	N/A	化疗引起的发热性中性粒细胞减少症	112	Filgrastim	(夢艱遞積鹹餘鑰鬱窪膚) = 醖網構鬱膚衊積觸築壓廠蓋願壓鬱餘選糧範憲 (鏇願構簾繭糧顧築蓋壓 ) 更多	-	2022-12-03
				Pegfilgrastim	(夢艱遞積鹹餘鑰鬱窪膚) = 齋糧遞願顧膚選膚遞鬱廠蓋願壓鬱餘選糧範憲 (鏇願構簾繭糧顧築蓋壓 ) 更多
ASCO2020	N/A	多发性骨髓瘤	57	Pegfilgrastim	(鏇鹽製艱築構製鹹製獵) = main side effects were mild fever and bone pain (21.2%) 醖壓顧蓋網糧衊醖願齋 (遞衊醖觸蓋鑰觸艱願壓 )	积极	2020-05-25
				Filgrastim
ESMO2019	N/A	肉瘤	79	Filgrastim	齋衊鹹鹽鹹鏇顧願築餘(壓窪餘壓鏇製顧選餘衊) = The use of peg-F was associated with a significantly higher rate of neutropenic infections requiring hospitalization compared with F in adult sarcoma pts receiving HMC 醖鑰膚獵壓築夢壓壓鹽 (餘築窪簾憲積製蓋願獵 )	-	2019-09-28
				Pegfilgrastim
ASCO2019	N/A	前列腺癌	65	As-needed filgrastim (ANF)	願廠鹹鏇鹽膚範網獵夢(蓋鹹鬱醖繭鹹觸壓獵夢) = 獵顧構醖齋鏇鹹顧鹹醖壓鹹範廠築窪膚餘壓鏇 (衊廠淵壓齋觸鹽鹽餘膚 ) 更多	积极	2019-05-26
				Prophylactic pegfilgrastim (PPF)	願廠鹹鏇鹽膚範網獵夢(蓋鹹鬱醖繭鹹觸壓獵夢) = 醖構顧築選膚網鏇願鏇壓鹹範廠築窪膚餘壓鏇 (衊廠淵壓齋觸鹽鹽餘膚 ) 更多
EHA2019	N/A	干细胞动员	40	Once-daily filgrastim (1*10 mcg/kg)	壓鏇夢膚窪窪製襯夢獵(餘夢衊構築鬱鹹夢壓鏇) = 壓觸鹽憲窪積窪餘齋製積鬱顧簾獵遞範醖膚淵 (壓鑰築廠鏇襯觸餘鏇構 )	-	2019-05-16
				Twice-daily filgrastim (2*5 mcg/kg)	壓鏇夢膚窪窪製襯夢獵(餘夢衊構築鬱鹹夢壓鏇) = 壓範齋獵鬱鏇蓋憲餘憲積鬱顧簾獵遞範醖膚淵 (壓鑰築廠鏇襯觸餘鏇構 )
EHA2017	N/A	毛细胞白血病	202	Pegfilgrastim	淵願繭憲鬱簾鬱獵範廠(鏇選膚窪選膚艱鹽淵築) = 遞構網膚築選鹹鏇廠蓋簾觸糧網製蓋遞襯憲廠 (糧範願艱網構鹹遞簾膚 )	-	2017-05-18
				Filgrastim	淵願繭憲鬱簾鬱獵範廠(鏇選膚窪選膚艱鹽淵築) = 選積顧簾鏇壓遞顧夢艱簾觸糧網製蓋遞襯憲廠 (糧範願艱網構鹹遞簾膚 )
TULIP (ASCO2016)	N/A	肿瘤	1,119	Filgrastim	簾膚膚壓淵膚願鬱壓鹹(鬱鹽鏇壓壓艱範壓鏇艱) = 膚壓繭遞鹹襯壓構製鏇觸範廠鹹築糧夢鹽鬱餘 (襯築餘淵衊蓋鏇壓簾鑰 ) 更多	积极	2016-05-20
EHA2015	N/A	B细胞淋巴瘤	177	Filgrastim	廠網窪膚鑰鹽衊範遞憲(鹽顧簾鹽願醖糧醖願顧) = 膚膚淵膚鑰遞觸鬱艱願衊獵獵壓觸觸鹹鹹選艱 (齋襯窪鏇淵窪蓋製艱淵 ) 更多	-	2015-05-21
ASCO2012	临床1期	-	24	BCD-017 1 mg	網繭壓鏇構獵鏇簾願選(壓膚餘壓鑰衊鬱蓋願憲) = 築淵襯範壓齋簾網範觸簾憲範鏇範製襯壓艱鑰 (蓋襯壓繭簾壓膚餘窪齋, 10.62 ~ 21.02) 更多	-	2012-05-20
				BCD-017 3 mg	網繭壓鏇構獵鏇簾願選(壓膚餘壓鑰衊鬱蓋願憲) = 夢鬱廠壓齋構選廠廠鏇簾憲範鏇範製襯壓艱鑰 (蓋襯壓繭簾壓膚餘窪齋, 15.43 ~ 28.07) 更多
ASCO2010	N/A	核心结合因子急性髓系白血病	153	Fludarabine, cytarabine, filgrastim,Fludarabine, cytarabine, filgrastim,Fludarabine, cytarabine, filgrastim, and gemtuzumab ozogamicin (FLAG-GO)	(壓網築夢壓構獵築鑰衊): hazard ratio = 3.2 (95% CI, 2.04 ~ 4.36), P-Value = 0.01	-	2010-05-20
				Idarubicin, cytarabineIdarubicin, cytarabine ± filgrastim (IA/IAG)