凝血因子XIII(Factor XIII(CSL Behring LLC)) - 药物靶点：Fibrinogen_在研适应症：术后出血，凝血因子XIII缺乏症，血管炎_专利_临床

概要

基本信息

药物类型

非重组凝血因子

别名

Blood coagulation factor XIII、Coagulation factor XIII、Corifact

+ [10]

靶点

Fibrinogen

作用方式-

作用机制

凝血因子XIII替代物

治疗领域

心血管疾病遗传病与畸形血液及淋巴系统疾病+ [1]

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

日本 (1994-09-01),

凝血因子XIII缺乏症血管炎

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 26728

关联

6

项与凝血因子XIII 相关的临床试验

NCT06481995

/ Recruiting临床4期IIT

Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial

The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH).
Summary of current body of evidence:
* Morbidity and mortality due to PPH is rising.
* Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy, despite non-conclusive evidence in all prospective trials.
* Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications; a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss.
Therefore, this nationwide, multi-center, randomized, controlled trial in multiple perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII.
All participating women receive, according to the national guideline, 1g tranexamic acid (TXA) i.v. in case of PPH (measured blood loss [MBL] ≥ 500 mL) during the pre-study phase. Randomization takes place if bleeding continues and exceeds 700mL. The intervention group then receives FXIII (Fibrogammin®) according to approved dosage in addition to obstetric standard of care treatment for causes of PPH; the control group receives only standard of care treatment.

开始日期2024-07-09

申办/合作机构

University of Zurich

[+1]

DRKS00016699

/ CompletedN/AIIT

Thrombelastographic investigation of the therapy of a dilutional coagulopathy with fibrinogen and factor XIII - WarmUp

开始日期2019-02-04

申办/合作机构-

NCT02551042

/ Unknown status临床2期IIT

A Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic Sclerosis

Many patients with Scleroderma (Systemic sclerosis) experience damage to blood vessels, mainly to the small arteries. A common manifestation of this is Raynaud's phenomenon (fingers or toes turning white then blue in the cold) and digital ulcers (open sores on the fingertips). The purpose of this study is to see how effective the study drug Human Factor XIII Concentrate is in treating patients who have these and other common manifestation of Scleroderma. It will be given in addition to the accepted treatments used for this disease.

开始日期2015-09-01

申办/合作机构

University College London

[+1]

100 项与凝血因子XIII 相关的临床结果

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100 项与凝血因子XIII 相关的转化医学

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100 项与凝血因子XIII 相关的专利（医药）

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147

项与凝血因子XIII 相关的文献（医药）

2026-02-01·Clinical Case Reports

A Case of Factor XIII Deficiency Identified by Recurrent Postoperative Bleeding After Tonsillectomy

Article

作者: Koichiro Wasano ; Ai Yamamoto ; Takanobu Teramura ; Akihiro Sakai ; Masashi Hamada ; Hikaru Yamamoto ; Kenji Okami

ABSTRACT:

Postoperative bleeding is a well‐known complication of tonsillectomy. Although inadequate hemostasis and vascular injury are common causes, occult coagulation disorders may also contribute. Factor XIII deficiency is an extremely rare condition that is particularly difficult to detect preoperatively because PT and APTT typically remain normal. A 27‐year‐old man underwent bilateral tonsillectomy for a recurrent peritonsillar abscess. Despite normal coagulation screening, the patient developed repeated postoperative hemorrhages requiring surgical management. Further evaluation revealed reduced Factor XIII activity (36%). After Factor XIII concentrate administration, bleeding ceased, and the postoperative course stabilized. Factor XIII deficiency should be considered in patients with recurrent postoperative bleeding despite normal routine coagulation tests. Early recognition and timely replacement therapy may prevent severe complications.

2025-10-21·Cureus Journal of Medical Science

Efficacy of Thoracic Duct Embolization in Managing Severe Refractory Chyle Leak Post-cervical Reconstruction in a Patient With Liver Cirrhosis: A Case Report

Article

作者: Nagaoka, Masato ; Kojima, Hiromi ; Ashida, Hirokazu ; Fukuda, Nobuki ; Ishida, Katsuhiro

This case report describes a patient with a history of liver cirrhosis who underwent neck reconstruction surgery and subsequently experienced substantial chyle leakage, reaching volumes of up to 6,620 mL per day. Conservative interventions such as fasting, a low-fat diet, total parenteral nutrition, drainage management, somatostatin analogs, and factor XIII supplementation proved ineffective, and the patient exhibited a refractory treatment course. The pronounced chyle leakage in this instance was hypothesized to be linked to increased lymph production resulting from portal hypertension associated with liver cirrhosis. Given the resistance to conservative treatment, thoracic duct embolization was performed by the interventional radiology department, effectively controlling the chyle leakage. The patient experienced a favorable clinical trajectory, devoid of complications. These findings indicate that thoracic duct embolization is a safe and efficacious minimally invasive treatment for refractory and massive chyle leakage following neck dissection and may represent a promising alternative before surgical intervention.

2025-08-04·Cureus Journal of Medical Science

Relief of Suspected IgA Vasculitis-Associated Enterocolitis Manifested as Severe Diarrhea and Hypoalbuminemia Treated With Glucocorticoid Therapy and Administration of Fibrogammin® (Purified Coagulation Factor XIII Concentrate): A Case Report

Article

作者: Aikawa, Takashi ; Iida, Tomohiro ; Negishi, Takashi

A 62-year-old female was admitted to our hospital with abdominal pain, diarrhea, and bloody stool. She suffered from severe diarrhea 30 times per day and consequently got hypoalbuminemia and hyponatremia. Esophagogastroduodenoscopy and total colonoscopy showed diffuse erosion of the duodenum, terminal ileum, and colorectum. Her endoscopic findings were similar to the former case reports of immunoglobulin A (IgA) vasculitis-associated enterocolitis. Further investigation of biopsy demonstrated that IgA-positive lymphocytes invaded the perivascular of the submucosal layer. However, we did not find IgA deposition in the capillary wall, and no granuloma, basal plasma cytosis, or crypt abscess was detected. Although a definite diagnosis could not be established, we considered the possibility of refractory IgA vasculitis-associated enterocolitis and initiated glucocorticoid therapy and administration of Fibrogammin® (purified coagulation factor XIII concentrate). The patient's diarrhea improved within one and a half months after admission.

100 项与凝血因子XIII 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	凝血因子XIII	B02BD07	DB12909

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
术后出血	美国	CSL Behring GmbH	2011-02-17
凝血因子XIII缺乏症	日本	CSL Behring LLC	1994-09-01
血管炎	日本	CSL Behring LLC	1994-09-01

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
系统性硬皮病	临床2期	英国	CSL Behring LLC	2015-09-01
弥漫性硬皮病	临床2期	英国	CSL Behring GmbH	2015-02-24
血友病	临床阶段不明	美国	CSL Behring LLC	2000-01-01

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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


NCT00883090 (Pubmed \| Haemophilia)	临床2期	凝血因子XIII缺乏症	15	FXIII concentrate (human) 40 IU kg(-1)	遞構憲獵選餘製憲顧顧(鹹製網淵襯膚膚窪遞鑰) = Two patients had possibly treatment-related adverse events 鹽觸廠憲簾願範積廠築 (製廠齋積顧鏇餘顧艱鹹 )	-	2015-01-01
NCT00883090 (CTgov)	临床2期	凝血因子XIII缺乏症	15	FXIII Concentrate (Human)	選糧鬱遞製製窪願憲觸(醖鏇廠願夢餘鬱願簾觸) = 蓋鹹選積齋構簾網餘餘繭鬱範鏇壓遞夢構蓋淵 (醖糧艱製鏇範遞願窪廠, 0.20) 更多	-	2012-01-16
Phase III study (ASH2006)	临床3期	-	61	Fibrogammin P	顧糧範網膚襯憲構齋選(網蓋構願衊築網選選網) = 齋積窪蓋積獵願廠窪鏇製網鹹獵簾製齋製遞廠 (願壓構衊鹽構衊觸艱糧 )	-	2006-11-16