卡法克坦(Calfactant) - 在研适应症：新生儿呼吸窘迫综合征，呼吸窘迫综合征_专利_临床

概要

基本信息

药物类型

生物药

别名

Bovactant、Calf lung surfactant extract (CLSE)、Calfactant (USAN)

+ [1]

靶点-

作用机制

细胞膜通透性增强剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段批准上市

首次获批日期

美国 (1998-07-01),

呼吸窘迫综合征

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

登录后查看时间轴

关联

9

项与卡法克坦相关的临床试验

NCT03748173 / Terminated临床1期

Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants

Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.

开始日期2019-01-12

申办/合作机构

ONY, Inc.

NCT03058666 / Completed临床3期

Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

开始日期2017-03-29

申办/合作机构

ONY, Inc.

NCT02834624 / CompletedN/AIIT

Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome

Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.
The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.

开始日期2013-07-01

申办/合作机构

University of Missouri

100 项与卡法克坦相关的临床结果

登录后查看更多信息

100 项与卡法克坦相关的转化医学

登录后查看更多信息

100 项与卡法克坦相关的专利（医药）

登录后查看更多信息

140

项与卡法克坦相关的文献（医药）

2024-10-01·American Journal of Physiology-Lung Cellular and Molecular Physiology

Comparative biophysical study of clinical surfactants using constrained drop surfactometry

Article

作者: Zuo, Yi Y.

A thorough investigation into the biophysical properties of four animal-derived clinical surfactant preparations was conducted through constrained drop surfactometry under physiologically relevant conditions. This comparative study unveiled unique in vitro biophysical characteristics among these clinical surfactants, establishing correlations between their chemical composition, lateral film structure, and biophysical functionality. The acquired knowledge offers essential insights for the precise and personalized design of clinical surfactant for the treatment of respiratory distress syndrome and other respiratory conditions.

2023-09-01·Archives of Medical Science

Comparative efficacy of pulmonary surfactant in respiratory distress syndrome in preterm infants: a Bayesian network meta-analysis

Review

作者: Fan, Nana ; Ma, Cui ; Zhang, Xiaoyu ; Zheng, Guofeng ; Qiu, Caihong

IntroductionThe comparative efficacy of pulmonary surfactant in the treatment of respiratory distress syndrome in preterm infants remains unclear. We aimed to evaluate the effectiveness of different pulmonary surfactant in the treatment of respiratory distress syndrome in preterm infants and to provide an evidence-based reference for clinical use.Material and methodsMEDLINE, Embase, The Cochrane Library, and Clinical Trials databases were electronically searched from inception to January 2019. Two reviewers independently screened literature and extracted data, and then R and RevMan 5.3 software packages were used to perform network meta-analysis.ResultsThe relative risk of respiratory distress syndrome in preterm infants associated with six different pulmonary surfactant was analysed, including beractant (Survanta), surfactant A (Alveofact), calfactant (Infasurf), poractant (Curosurf), lucinactant (Surfaxin), and colfosceril (Exosurf). Patients with the following drugs appeared to have significantly reduced mortality of respiratory distress syndrome compare with beractant: surfactant A (OR = 0.53, 95% CI: 0.31–0.90), calfactant (OR = 0.91, 95% CI: 0.85–0.97), poractant (OR = 0.72, 95% CI: 0.67–0.77), lucinactant (OR = 0.80, 95% CI: 0.71–0.90), and colfosceril (OR = 0.93, 95% CI: 0.87–0.99). The SUCRA (surface under the cumulative ranking) values for each of the drugs were: beractant (8.9%), surfactant A (93.8%), calfactant (40.3%), poractant (65.4%), lucinactant (59.8%), and colfosceril (31.6%).ConclusionsCompared with beractant, other pulmonary surfactants are more effective to reduce the mortality of respiratory distress syndrome in preterm infants. Surfactant A drugs appeared to have the best efficacy in reducing mortality of respiratory distress syndrome in preterm infants.

2023-08-31·mBio

A new tractable method for generating human alveolar macrophage-like cells in vitro to study lung inflammatory processes and diseases.

Article

作者: Jarvis, Natalie ; Arnett, Eusondia ; Lai, Zhao ; Schlesinger, Larry S ; Guerrero-Arguero, Israel ; Pahari, Susanta ; Torrelles, Jordi B ; Lumbreras, Miranda ; Zhang, Hao ; Ye, Chengjin ; Simper, Jan ; Azad, Abul ; Wang, Yufeng ; Maselli, Diego Jose ; Martinez-Sobrido, Luis ; Cai, Hong ; Peters, Jay

Alveolar macrophages (AMs) are unique lung resident cells that contact airborne pathogens and environmental particulates. The contribution of human AMs (HAMs) to pulmonary diseases remains poorly understood due to the difficulty in accessing them from human donors and their rapid phenotypic change during in vitro culture. Thus, there remains an unmet need for cost-effective methods for generating and/or differentiating primary cells into a HAM phenotype, particularly important for translational and clinical studies. We developed cell culture conditions that mimic the lung alveolar environment in humans using lung lipids, that is, Infasurf (calfactant, natural bovine surfactant) and lung-associated cytokines (granulocyte macrophage colony-stimulating factor, transforming growth factor-β, and interleukin 10) that facilitate the conversion of blood-obtained monocytes to an AM-like (AML) phenotype and function in tissue culture. Similar to HAM, AML cells are particularly susceptible to both Mycobacterium tuberculosis and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. This study reveals the importance of alveolar space components in the development and maintenance of HAM phenotype and function and provides a readily accessible model to study HAM in infectious and inflammatory disease processes, as well as therapies and vaccines. IMPORTANCE Millions die annually from respiratory disorders. Lower respiratory track gas-exchanging alveoli maintain a precarious balance between fighting invaders and minimizing tissue damage. Key players herein are resident AMs. However, there are no easily accessible in vitro models of HAMs, presenting a huge scientific challenge. Here, we present a novel model for generating AML cells based on differentiating blood monocytes in a defined lung component cocktail. This model is non-invasive, significantly less costly than performing a bronchoalveolar lavage, yields more AML cells than HAMs per donor, and retains their phenotype in culture. We have applied this model to early studies of M. tuberculosis and SARS-CoV-2. This model will significantly advance respiratory biology research.

100 项与卡法克坦相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D03317	卡法克坦	R07AX	DB06415

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
新生儿呼吸窘迫综合征	土耳其	-	2018-10-31
新生儿呼吸窘迫综合征	马来西亚	-	2018-10-31
呼吸窘迫综合征	美国	ONY, Inc.	1998-07-01

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
毛细支气管炎	临床1期	美国	ONY, Inc.	2019-01-12
毛细支气管炎	临床1期	美国	ONY Agency LLC	2019-01-12
急性肺损伤	临床1期	美国	-	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02834624 (NEOSURF, CTgov)	N/A	呼吸窘迫综合征	30	calfactant (Calfactant)	襯獵鏇蓋簾憲衊餘鏇艱(蓋憲鏇夢蓋鏇簾鹹窪積) = 鬱鏇鏇淵鹽鹽窪窪壓構範簾餘蓋顧簾襯簾顧願 (鏇觸蓋網夢願築遞衊繭, 遞齋選製獵襯繭範憲艱 ~ 壓鏇築構衊鑰鹹鹹蓋壓) 更多	-	2017-06-06
				Poractant alfa (Poractant Alfa)	顧餘顧遞網願鏇遞觸鹹(範夢襯窪鹽簾壓願襯製) = 鹹壓鹹窪選網鏇製觸夢網鬱艱鹹餘糧簾鹹鹽獵 (遞夢夢淵築繭願網夢憲, 鏇繭積艱醖網觸鏇鏇願 ~ 壓積繭餘夢淵顧選網齋) 更多
NCT00569530 (TOLSURFPilot, CTgov)	临床3期	支气管肺发育不良 \| 表面活性剂功能障碍	85	Infasurf (ONY Inc.) (Treatment Surfactant (Infasurf) ONY, NY)	衊積構遞齋製遞網獵糧(鏇繭夢壓築鑰窪範鏇壓) = 鬱積範簾範齋網糧範觸夢獵築網蓋衊願壓鑰積 (窪壓範簾築鹽齋繭艱淵, 夢繭襯網顧夢鹹襯淵蓋 ~ 壓積簾壓鹹製窪築襯齋) 更多	-	2016-06-28
				Sham (Sham (no Treatment))	衊積構遞齋製遞網獵糧(鏇繭夢壓築鑰窪範鏇壓) = 觸築觸襯廠廠選觸窪顧夢獵築網蓋衊願壓鑰積 (窪壓範簾築鹽齋繭艱淵, 壓選醖廠膚簾遞夢窪簾 ~ 鹹顧構鏇繭築糧獵膚製) 更多