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-

作用方式

增强剂

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)

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关联

10

项与卡法克坦相关的临床试验

NCT06855043

/ Not yet recruiting临床2期IIT

Pilot Study of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Infants

This clinical trial is being done to evaluate the clinical response and safety of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.
The main questions it aims to answer are:
* Do the combined drugs improve the respiratory severity score (RSS)
* Is the combination safe
Participants will receive three doses of the study drug.

开始日期2025-06-01

申办/合作机构

University of Wisconsin Madison

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.

100 项与卡法克坦相关的临床结果

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100 项与卡法克坦相关的转化医学

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100 项与卡法克坦相关的专利（医药）

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134

项与卡法克坦相关的文献（医药）

2025-01-01·Journal of Perinatology

High vs low CPAP strategy with aerosolized calfactant in preterm infants with respiratory distress syndrome

Article

作者: Gerday, E ; Kaluarachchi, D C ; Lasarev, M R ; Guthrie, S O ; Zapata, H A ; Minton, S ; Bahr, T

BACKGROUNDOptimal CPAP strategy to prevent CPAP failure defined as need for endotracheal intubation is unknown.OBJECTIVETo evaluate the risk of CPAP failure in infants treated with high vs low CPAP strategy while receiving aerosolized calfactant in the AERO-02 clinical trial and AERO-03 expanded access program.METHODSInfants born between 29 0/7 to 36 6/7 weeks were included. Comparisons were made between low and high CPAP groups (Low, 4-7 cm H₂O; High, 8-10 cm H₂O).RESULTSCPAP failure and pneumothorax were not different between the groups. Odds of CPAP failure were not different after adjustment for baseline characteristics (OR = 0.61; 95% CI: 0.29, 1.24).CONCLUSIONWe found no difference in CPAP failure among infants who received aerosolized calfactant that were treated with high vs low CPAP strategy. Efficacy of high CPAP strategy with aerosolized surfactant treatment needs to be evaluated in future studies.

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.

2024-06-01·The Journal of Pediatric Pharmacology and Therapeutics

Comparison of Efficacy and Pharmacoeconomic Outcomes Between Calfactant and Poractant Alfa in Preterm Infants With Respiratory Distress Syndrome

Article

作者: Schumann, Caitlin ; Le, Jennie ; Bui, Annie ; Jones, Treva ; Schwendeman, Clair

OBJECTIVESIn order to evaluate the impact of the surfactant of choice selection, primary end points were to compare the average number of doses per patient, need for mechanical ventilation on day 3, hospital length of stay, and in-hospital mortality between calfactant and poractant alfa in preterm infants with respiratory distress syndrome (RDS). Secondary outcomes included administration complications, development of bronchopulmonary dysplasia (BPD), and estimated average per patient cost among the study population.METHODSA retrospective chart review was performed at a level IV neonatal intensive care unit between January 2020 and December 2021 to compare the efficacy, safety, and pharmacoeconomic outcomes following a surfactant of choice switch from calfactant to poractant alfa in preterm infants with RDS.RESULTSFinal analysis included 253 premature infants with gestational age (GA) between 22 and 36 weeks who met inclusion criteria. A total of 118 patients who received calfactant required higher average number of doses, 1.5 vs 1.3 doses (p = 0.031), and had more administration complications than 135 patients who received poractant alfa (10.2 vs 2.2%, p = 0.008). The need for redosing, mechanical ventilation on day 3, hospital length of stay, in-hospital mortality, and development of BPD were comparable between both groups. However, the estimated average per patient cost for poractant alfa was 32% higher than calfactant ($1,901 vs $1,439, p <0.001).CONCLUSIONSDespite the pharmacoeconomic disadvantage, preterm infants who received poractant alfa needed fewer doses and were less likely to have administration complications compared with those who received calfactant.

100 项与卡法克坦相关的药物交易

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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,

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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,

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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2期	美国	ONY, Inc.	2019-01-12
毛细支气管炎	临床2期	美国	ONY Agency LLC	2019-01-12
急性肺损伤	临床1期	美国	-	-

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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


NCT02834624 (NEOSURF, CTgov)	N/A	呼吸窘迫综合征	30	calfactant (Calfactant)	壓廠製範鹽鬱壓廠構襯(構築範壓壓憲簾鬱選遞) = 鹹鏇壓糧觸遞淵膚鏇鏇襯觸範衊觸獵窪醖艱淵 (鹹簾壓壓範壓壓夢憲願, 網積衊餘構齋顧蓋選構 ~ 獵淵鏇觸餘夢觸艱積積) 更多	-	2017-06-06
				Poractant alfa (Poractant Alfa)	襯築膚鬱遞鹹醖鹹鬱範(艱蓋願壓鑰選醖膚衊膚) = 鑰選衊淵網齋艱願夢窪鏇獵築艱蓋糧鹽鏇鬱夢 (齋齋鑰網顧範齋網膚淵, 膚構衊衊鹹淵網選鹹願 ~ 鹽襯艱憲窪獵選遞築觸) 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)	範壓鹽衊餘鏇糧築網構(積觸範網遞遞艱膚廠憲) = 鹹壓蓋顧選醖築餘膚鹽蓋簾範鏇鏇觸積餘鬱鑰 (壓觸鏇窪簾窪構鹽夢窪, 廠製糧襯齋壓觸製壓鹹 ~ 衊鬱廠範範夢艱鏇壓艱) 更多	-	2016-06-28
				Sham (Sham (no Treatment))	範壓鹽衊餘鏇糧築網構(積觸範網遞遞艱膚廠憲) = 憲糧願艱鏇選憲餘膚憲蓋簾範鏇鏇觸積餘鬱鑰 (壓觸鏇窪簾窪構鹽夢窪, 憲簾醖築遞窪鹹遞糧餘 ~ 選糧願製網鑰範網顧憲) 更多