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-

作用方式-

作用机制-

治疗领域

免疫系统疾病神经系统疾病其他疾病

在研适应症-

非在研适应症

多灶性运动神经病慢性炎症性脱髓鞘性多发性神经病

原研机构

Baxalta Innovations GmbH

在研机构-

非在研机构

Baxter Healthcare Ltd

权益机构-

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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关联

3

项与人血丙种球蛋白相关的临床试验

CTIS2023-505053-40-00

/ Recruiting临床2期IIT

Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD

开始日期2023-12-07

申办/合作机构-

NCT02556437

/ Completed临床2期IIT

Randomized, Single-blind, Cross-over Study Investigating the Non-inferiority of Efficacy and Safety of HyQvia in Comparison With Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy

The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin 10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment in patients with Multifocal Motor Neuropathy (MMN).

开始日期2016-06-01

申办/合作机构

Rigshospitalet

[+1]

NCT00268788

/ Completed临床2期IIT

A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy

The purpose of this study is to evaluate the effect of subcutaneous administration of immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy
NB. ONLY RECRUITING FROM DENMARK

开始日期2005-08-01

申办/合作机构

University of Aarhus

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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33

项与人血丙种球蛋白相关的文献（医药）

2024-09-01·Cureus

When a Child Refuses to Play: A Rare Myopathy

Article

作者: Moura Antunes, Sofia ; Martins, Mafalda ; Madureira, Inês ; Dias, Susana ; Condessa, Luzia

Idiopathic inflammatory myopathies (IIM) are a rare group of systemic diseases characterized by progressive proximal muscle weakness and skeletal muscle inflammation. We describe a clinical report of a seven-year-old boy presenting with myalgia and proximal muscle weakness beginning three weeks earlier, with laboratory, MRI, and muscle biopsy findings consistent with IIM. The patient was treated with corticosteroids, methotrexate, immunoglobulin, and intensive motor rehabilitation, with favorable evolution. Diagnosis of Juvenile Polymyositis was confirmed. Three years later, we assisted a relapse of muscle weakness and muscle cytolysis with the onset of bilateral eyelid skin microulcers compatible with dermatomyositis. This report intends to highlight the importance of early diagnosis and treatment in IIM due to the significant burden associated with this group of diseases. In this case, the late onset of the skin lesion contributed to the challenge in this diagnosis.

2024-01-01·International Archives of Allergy and Immunology

Facilitated Subcutaneous Immunoglobulin Treatment Increases the Quality of Life and Decreases the Number of Infections and Hospitalizations in Children with Primary Immunodeficiencies

Article

作者: Edeer Karaca, Neslihan ; Erbaş Açıcı, Nida ; Aygün, Ayşe ; Kutukculer, Necil ; Geyik, Mehmet ; Topyildiz, Ezgi ; Aksu, Guzide

Introduction: Immunoglobulin replacement therapy is an effective lifelong treatment modality used in patients with primary immunodeficiency to prevent and/or reduce the incidence of serious infections. Facilitated subcutaneous immunoglobulin (fSCIG) was developed to combine the advantages of intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) and is the latest method of immunoglobulin G (IgG) administration. In this study, switching to fSCIG administration in primary immunodeficiency patients receiving regular IVIG or SCIG therapy was evaluated, and serum IgG trough levels, frequency of infections, frequency and duration of hospitalizations, duration of absence from school/work, and quality of life were determined. Methods: In this study, fifteen patients with primary immunodeficiency who were previously receiving IVIG or SCIG treatment, followed by fSCIG, were evaluated retrospectively. Age, diagnosis, current complications, mean IgG value, frequency of infection, frequency of hospitalization, and duration of absenteeism from school and work were recorded during and before fSCIG treatment. At the beginning of fSCIG treatment, at 6th and 12th months, “The Quality of Life Scale” was also evaluated in patients and parents. Results: The most common indications for initiation of fSCIG treatment were the difficulty of access to the hospital and the long transfusion periods. No systemic adverse reactions were reported except for redness, swelling, and mild pain on the injection site. The median IgG values for the last 1 year were 529.6 mg/dL for IVIG (n = 9), 876.2 mg/dL for SCIG (n = 6) and 856.7 mg/dL for fSCIG (n = 15, all patients) treatment. The frequency of infections and the number of hospitalizations decreased significantly in the fSCIG group compared to both previous treatment modalities. There was a significant increase in the quality of life score of the patients and their families when compared with previous treatment modalities. Conclusion: fSCIG is an effective treatment method and is well tolerated in patients with immunodeficiency. It provides stable immunoglobulin levels and excellent protection against infections and offers the patients the possibility of home-based therapy.

2023-09-01·Revista alergia Mexico (Tecamachalco, Puebla, Mexico : 1993)

[Absceso cerebral como manifestación inicial de Deficiencia especifica de anticuerpos].

Article

作者: Del Río-Navarro, Blanca ; Jiménez-Vázquez, Leysi Nury ; Saucedo-Ramírez, Omar Josué

BackgroundSpecific antibody deficiency (SAD) is an inborn error of immunity, in patients older than 2 years, characterized by normal immunoglobulin levels and IgG subclasses, but with recurrent infections and decreased antibody responses to polysaccharide antigens.Case reportA 10-year-old female, previously healthy, with no significant family history. She is known in this institution for symptoms of headache, vomiting and paresis. A CT scan of the skull was performed, where 4 brain abscesses, edema and displacement of the midline were observed, a right frontal trephine was performed and abscess drainage, antimicrobial management for infectology, blood cultures, Gram staining and cultures of negative drainage material. Assessed for allergy and immunology, for abscesses in deep focus, an approach was performed to rule out inborn error of immunity, immunoglobulins, isohemagglutinins, flow cytometry and response to normal protein antigens. Antibodies against post-vaccination polysaccharide antigens are requested, where a response to only 2 serotypes (18.1% response) is observed, with normal IgG subclasses, a diagnosis of specific antibody deficiency is integrated and management with immuno- globulin at replacement doses is started, as well as annual vaccination with 13 valent.ConclusionSAD has been considered a problem that can be resolved over time, especially in children, but in others it can evolve into more severe forms of humoral immunodeficiency. Decisions to treat with prophylactic antibiotics and/or gamma globulin are guided by clinical judgment, small studies, and recent consensus documents, which may evolve over time.

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

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
多灶性运动神经病	临床2期	丹麦	Baxter Healthcare Ltd	2016-06-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	丹麦	Baxter Healthcare Ltd	2010-04-01