人血丙种球蛋白(Immunoglobulin(Baxalta Innovations GmbH))

概要

基本信息

药物类型

免疫球蛋白

别名

human normal immunoglobulin(Baxter )、Subcuvia

靶点-

作用机制-

治疗领域-

在研适应症-

非在研适应症-

原研机构

Baxalta Innovations GmbH

在研机构

Baxalta Innovations GmbH

非在研机构-

最高研发阶段批准上市

首次获批日期

德国 (2004-08-05)

最高研发阶段(中国)-

特殊审评-

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关联

42

项与人血丙种球蛋白相关的临床试验

ACTRN12623001336673

/ Not yet recruiting临床2期IIT

Comparing Use of B-cell depletion therapy to Immunoglobulin in Chronic inflammatory demyelinating polyneuropathy (CUBIC) clinical trial.

开始日期2024-08-05

申办/合作机构

Western Sydney Local Health District

PACTR202411838959146

/ RecruitingN/AIIT

Effect of Intravenous Immunoglobulin as Adjuvant Therapy for Septic Shock Patients Admitted to Alexandria University Pediatric Intensive Care Unit

开始日期2024-05-01

申办/合作机构-

CTRI/2023/08/056013

/ Not yet recruitingN/A

USE OF IV IMMUNOGLOBULIN MIXTURE IN THE TREATMENT OF BURN SEPSIS: A RANDOMIZED CONTROL TRIAL - NIL

开始日期2023-08-19

申办/合作机构

All India Institute of Medical Sciences

100 项与人血丙种球蛋白相关的临床结果

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100 项与人血丙种球蛋白相关的转化医学

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100 项与人血丙种球蛋白相关的专利（医药）

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255

项与人血丙种球蛋白相关的文献（医药）

2024-07-03·British Poultry Science

Expression of genes related to ileal barrier function in heritage and modern broiler chickens

Article

作者: Proszkowiec-Weglarz, M. ; Miska, K. B. ; Kpodo, K. R. ; Schreier, L. L.

1. An experiment was conducted to determine differences in the expression of genes encoding intestinal barrier proteins between fast, medium and slow-growing chickens. Chicken breeds Athens Canadian Random Bred (ACRB), Longenecker's Heritage (LHR), RedBro, Hubbard H1 (HH1), Cobb500 and Ross708 were raised from hatch for 35 d.2. Ileal samples were collected at embryonic day E19 (-2 days post-hatch), hatch and d 7, 14, 21, 28 and 35 post-hatch to assess the expression of genes encoding tight junction proteins (claudins, CLDN; occludin, OCLN; zonula occludens, ZO; and junctional adhesion molecules, JAM), mucin (Muc2), immunoglobulin A (IgA), polymeric immunoglobulin receptor (pIgR) and fatty acid binding protein (FABP2).3. Expression of CLDN-1 was increased (p < 0.0001) in LHR compared to Cobb500 while CLDN-5 was increased (p < 0.0001) in ACRB, HH1, RedBro and Ross708 compared to LHR as well as in ACRB compared to Cob500. Occludin was upregulated (p = 0.01) in ACRB and LHR compared to Ross708 at d 14 post-hatch. Expression of ZO-1 was upregulated (p = 0.001) in LHR compared to Ross708, HH1 and Cobb500. Tight junction genes, except CLDN-4, JAM-2 and JAM-3 were downregulated (p < 0.0001) at hatch and d 7 post-hatch. Expression of Muc2 was increased (p < 0.0001) in LHR compared to RedBro and from -2 d to d 7 post-hatch.4. Immunoglobulin A was increased (p = 0.001) in LHR compared to Ross708 and HH1 at -2 d post-hatch and in LHR compared to ACRB, Cobb500 and Ross708 at hatch. In addition, IgA expression was increased in all breeds at d 14 post-hatch while pIgR was upregulated (p = 0.02) in Cobb500 and Ross708 compared to ACRB, HH1, LHR and RedBro at hatch.5. The gene expression patterns suggest that selection for growth may have not induced changes in junctional complexes and immune defence genes. However, the results confirmed that the expression of these genes is age dependent.

2024-07-01·American Heart Journal

Different dose aspirin plus immunoglobulin (DAPI) for prevention of coronary artery abnormalities in Kawasaki disease: Study protocol for a multi-center, prospective, randomized, open-label, blinded end-point, non-inferiority trial

Article

作者: Li, Ming ; Zhang, Xu ; Li, Wei ; Xie, Xiaofei ; Yuan, Jia ; Zhang, Li ; Li, Jianbin ; Wang, Yanfei ; Li, Fengxiang ; Wu, Yujian ; Hu, Lin ; Huang, Ping ; Xia, Shuliang ; Wang, Zhouping

BACKGROUNDKawasaki disease is a pediatric acute systemic vasculitis that specifically involves the coronary arteries. Timely initiation of immunoglobulin plus aspirin is necessary for diminishing the incidence of coronary artery abnormalities (CAAs). The optimal dose of aspirin, however, remains controversial. The trial aims to evaluate if low-dose aspirin is noninferior to moderate-dose in reducing the risk of CAAs during the initial treatment of Kawasaki disease.METHODSThis is a multi-center, prospective, randomized, open-label, blinded endpoint, noninferiority trial to be conducted in China. The planned study duration is from 2023 to 2026. Data will be analyzed according to intention-to-treat principles. Participants are children and adolescents under the age of 18 with Kawasaki disease, recruited from the inpatient units. A sample size of 1,346 participants will provide 80% power with a one-sided significance level of 0.025. Qualifying children will be randomized (1:1) to receive either intravenous immunoglobulin (2 g/kg) plus oral moderate-dose aspirin (30-50 mg·kg^-1·d^-1) until the patient is afebrile for at least 48 hours, or immunoglobulin plus low-dose aspirin (3-5 mg·kg^-1·d^-1) as initial treatment. The primary outcome will be the occurrence of CAAs at 8 weeks after immunoglobulin infusion. Independent blinded pediatric cardiologists will assess the primary endpoint using echocardiography.CONCLUSIONSThere is a shortage of consensus on the dose of aspirin therapy for Kawasaki disease due to the lack of evidence. The results of our randomized trial will provide more concrete evidence for the efficacy and adverse events of low- or moderate-dose aspirin in the acute phase of Kawasaki disease.TRIAL REGISTRATIONwww.chictr.org.cn: ChiCTR2300072686.

2024-04-09·Blood Advances

Immunoglobulin replacement vs prophylactic antibiotics for hypogammaglobulinemia secondary to hematological malignancy

Article

作者: Dendle, Claire ; Pepperell, Dominic ; Degelia, Amber ; Morrissey, C. Orla ; Wood, Erica M. ; Weinkove, Robert ; Keegan, Anastazia ; Gilbertson, Michael ; Weston, Helen ; Waters, Neil ; Crispin, Philip ; McQuilten, Zoe K. ; Wellard, Cameron ; Thao, Le Thi Phuong ; Pullon, Humphrey ; Johnston, Anna ; van Tonder, Tina ; Trotman, Judith ; Reynolds, John

AbstractImmunoglobulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared. In this randomized controlled feasibility trial conducted in 7 hospitals in Australia and New Zealand, we enrolled patients with secondary hypogammaglobulinemia with either a history of recurrent/severe infection or an immunoglobulin G level <4 g/L. Participants were randomized in a 1:2 ratio to immunoglobulin (0.4 g/kg per 4 weeks IV) or daily antibiotics (trimethoprim-sulfamethoxazole 160 mg/800 mg or, if contraindicated, 100 mg doxycycline) for 12 months. Participants allocated to antibiotics were allowed to crossover after grade ≥3 infections. The primary outcome was proportion of patients alive on the assigned treatment 12 months after randomization. Between August 2017 and April 2019, 63 patients were randomized: 42 to antibiotics and 21 to immunoglobulin. Proportion of participants alive on allocated treatment at 12 months was 76% in the immunoglobulin and 71% in the antibiotic arm (Fisher exact test P=.77; odds ratio, 0.78; 95% CI, 0.22-2.52). The lower quartile for time to first major infection (median, not reached) was 11.1 months for the immunoglobulin and 9.7 months for the antibiotic arm (log-rank test, P=.65). Three participants in the immunoglobulin and 2 in the antibiotic arm had grade ≥3 treatment-related adverse events. A similar proportion of participants remained on antibiotic prophylaxis at 12 months to those on immunoglobulin, with similar rates of major infections. Our findings support the feasibility of progressing to a phase 3 trial. Trial registration #ACTRN12616001723471.

100 项与人血丙种球蛋白相关的药物交易

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研发状态

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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


EHA2022	N/A	多发性骨髓瘤	2,445	IMMUNOGLOBULIN (Patients who received Ig)	襯壓艱壓廠齋淵鏇構齋(醖廠窪廠艱蓋鑰觸襯鹽) = 鑰網簾獵構鏇蓋遞網繭範願醖鹹艱醖壓顧選鑰 (窪簾鹽鬱願顧膚構鬱憲 )	-	2022-05-12
				IMMUNOGLOBULIN (Patients who did not receive Ig)	襯壓艱壓廠齋淵鏇構齋(醖廠窪廠艱蓋鑰觸襯鹽) = 餘構鏇襯淵艱鏇鏇觸鹽範願醖鹹艱醖壓顧選鑰 (窪簾鹽鬱願顧膚構鬱憲 )
P5.044 (AAN2016)	N/A	慢性炎症性脱髓鞘性多发性神经病 \| 多发性骨髓瘤	-	IVIG	(衊衊鬱遞鬱醖齋糧繭獵) = 鏇艱鏇獵醖醖範夢膚廠鬱鬱憲餘艱艱觸夢糧鹽 (鬱網壓製鬱餘鹽壓蓋願 ) 更多	-	2016-04-05
				Immunoglobulin	(衊衊鬱遞鬱醖齋糧繭獵) = 餘簾獵積糧範構鬱鹹糧鬱鬱憲餘艱艱觸夢糧鹽 (鬱網壓製鬱餘鹽壓蓋願 ) 更多
SP153 (ERA2015)	N/A	膜性肾小球肾炎 IgG \| IgM \| IgA	61	IMMUNOGLOBULIN (rich form LMN)	(醖構鹽壓選糧襯築觸蓋) = 壓築艱製鏇獵餘憲醖選餘築壓鬱獵齋製夢艱繭 (鹹觸選憲餘鏇餘遞襯淵 )	不佳	2015-05-21
				IMMUNOGLOBULIN (poor form LMN)	(願積願鏇願網觸遞窪觸) = 蓋製醖簾襯膚窪壓襯網憲製繭鏇膚遞鹹選鏇鏇 (鬱鏇鹽衊鏇顧簾壓積網 ) 更多