Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh)(Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh)) - 药物靶点：Fibrinogen x prothrombin_在研适应症：组织粘连，出血，凝血障碍_专利_临床

概要

基本信息

药物类型

重组凝血因子

别名

Fibrin Sealant Patch, Absorbable(Takeda Pharma)、Fibrin sealant patch (Takeda)、Human fibrinogen/Human thrombin(CSL Behring)

+ [5]

靶点

Fibrinogen x prothrombin

作用机制

纤维蛋白原调节剂、prothrombin调节剂(凝血酶原调节剂)

治疗领域

神经系统疾病血液及淋巴系统疾病其他疾病

在研适应症

组织粘连出血凝血障碍+ [2]

非在研适应症

术中并发症肝病肺部疾病

原研机构

Takeda Pharmaceuticals International AG

在研机构

Corza Medical GmbHTakeda Pharma A/STakeda Pharmaceuticals International, Inc.

+ [2]

非在研机构

Nycomed BV

最高研发阶段批准上市

首次获批日期

奥地利 (1992-12-31),

创伤和损伤

最高研发阶段(中国)-

特殊审评-

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关联

34

项与 Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh) 相关的临床试验

NCT06664775 / Not yet recruiting临床3期

An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.

The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for > 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.

开始日期2024-11-25

申办/合作机构

Corza Medical GmbH

NCT06124209 / Recruiting临床4期IIT

Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial

The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.
The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.

开始日期2023-11-04

申办/合作机构

Warszawski Uniwersytet Medyczny

NL-OMON53880 / SuspendedN/A

A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery - Safety/efficacy of GATT-Patch vs TachoSil During Open Liver Surgery

开始日期2022-07-25

申办/合作机构

GATT Technologies BV

100 项与 Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh) 相关的临床结果

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100 项与 Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh) 相关的转化医学

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100 项与 Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh) 相关的专利（医药）

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367

项与 Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh) 相关的文献（医药）

2025-01-01·Biomaterials Advances

Development of a Janus tissue adhesive hemostatic patch based on hydrophobically-modified Alaska pollock gelatin

Article

作者: Komatsu, Hiyori ; Ito, Shima ; Maki, Naoki ; Sugai, Kazuto ; Taguchi, Tetsushi ; Nagasaka, Kazuhiro ; Tai, Tetsuo ; Sato, Yukio ; Palai, Debabrata ; Watanabe, Shiharu ; Kawamura, Tomoyuki

Uncontrollable hemorrhage from trauma and open surgery leads to a high percentage of death. Even though some patch-type hemostatic materials have been used in the clinic, sufficient tissue adhesion property and the management of tissue adhesion and anti-adhesion have been the challenges. In this report, we designed Janus tissue adhesive hemostatic patch, consisting of Alaska pollock gelatin (Org-ApGltn) as a support layer and decanoyl group-modified ApGltn (C10-ApGltn) with pentaerythritol poly(ethylene glycol) ether tetrasuccinimidyl glutarate (4S-PEG) as an adhesive layer, named as the C10-ApGltn patch. The C10-ApGltn patch adhered onto blood vessel surface by the activation 4S-PEG and hydrophobic groups in C10-ApGltn through the covalent bond formation and physical interaction. The burst strength of the C10-ApGltn patch was optimized in terms of the degree of substitution, the molecular weight of 4S-PEG, the concentration of C10-ApGltn, and the NHS/NH₂ ratio. The optimized C10-ApGltn patch showed significantly higher burst strength with commercially available TachoSil®. The C10-ApGltn patch showed enzymatic degradability in a buffer solution with collagenase. In a rat liver hemorrhage model, the C10-ApGltn patch acted as a sealant on the hemorrhage site and exhibited competitive hemostatic property to TachoSil®.

2024-09-03·Cureus

Early Esophageal Perforation Following Anterior Cervical Discectomy and Fusion Treated With Controlled Esophageal Fistula and TachoSil® Coverage: A Case Report

Article

作者: Massoud, Nagi A ; Alashkar, Abdulrahman H ; Aljawash, Mohammad A ; Massoud, Nagi A ; Aljawash, Mohammad A ; Al-Rawashdeh, Feras

Anterior cervical discectomy and fusion (ACDF) is a commonly performed procedure. One of its most feared complications is esophageal injury (EI). There is no standard approach on how to treat these injuries. TachoSil^® (Corza Medical GmbH, Düsseldorf, Germany) is a fibrinogen-containing patch that has been used in various surgical areas. Here, we present a 68-year-old male patient who was diagnosed with an EI with secondary surgical site infection following a three-level ACDF (C4/5, C5/6, and C6/7). Initially, the patient underwent incision and drainage (I&D) of the surgical site abscess, primary repair of the esophageal tear, and esophageal catheter placement to create a controlled esophagocutaneous fistula. Postoperatively, he was diagnosed with a leak and underwent a second I&D procedure. The primary repair of the EI was augmented with a TachoSil patch, and the patient was started on glycopyrrolate. The site of EI was well-sealed with no re-leaks, and the patient was discharged after he had completed a course of intravenous (IV) antibiotics and had been on parenteral nutrition for a total of 40 days. This case shows that the use of TachoSil to augment the repair of ACDF-associated EI, and glycopyrrolate to decrease salivation could decrease the risk of leak and enhance the healing process. This is an observation that needs to be scrutinized in future studies.

2024-09-01·Updates in Surgery

Long-term persistence of carrier-bound fibrin sealant (TachoSil®) following abdominal surgery: a decade-long follow-up study

Article

作者: Terrasi, Alessandro ; Rapisarda, Martina ; Di Carlo, Isidoro ; Toro, Adriana

This study analyzed the long-term effects of carrier-bound fibrin sealant (CBFS) following abdominal surgery by tracking patients for years post-application. From 2006 to 2022, patients who underwent this procedure were contacted via telephone. Those who died due to underlying diseases, natural causes, or refused the check-up were excluded from the study. After 11 years of follow-up, CBFS was observed in different forms on computed tomography scans in four patients. Our findings indicate that CBFS can persist for years after the procedure. While we cannot confirm any secondary effects, it appears that CBFS sponges are not resorbed within 12 weeks and can remain for many years post-implantation.

1

项与 Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh) 相关的新闻（医药）

2021-02-02

·NS Medical Devices

GTCR wraps up acquisition of Surgical Specialties

Surgical Specialties is engaged in the production of surgical sutures and ophthalmic knives GTCR has completed the acquisition of medical devices manufacturer Surgical Specialties. (Credit: Adam Radosavljevic from Pixabay) GTCR portfolio company Corza Health has completed the acquisition of US-based medical technology firm Surgical Specialties from a consortium led by ZQ Capital and Vivo Capital. The consortium, including co-investors Aretex Capital Partners, China Orient Asset Management (International) Holding, Fung Shing Investments, FS KKR Capital, Cathay Venture and Nan Fung Group, acquired Surgical Specialties in 2017. Based in Westwood of Massachusetts, Surgical Specialties has expertise in the manufacturing of surgical sutures and ophthalmic knives. Since 2017, Surgical Specialties acquired three companies and sold one product line to Angiodynamics. The company has also constructed two factories in the US and China. Surgical Specialties merges with TachoSil Corza Health has merged Surgical Specialties with the TachoSil Fibrin Sealant Patch to establish a new company called Corza Medical. TachoSil, earlier owned by Takeda Pharmaceutical, is a surgical patch product line that facilitates safe and fast bleeding control during surgeries. Corza Medical will provide a platform of surgical technologies, including brands such as Quill barbed sutures, Sharpoint Plus and Look surgical sutures, Sharpoint ophthalmic knives, and the TachoSil Fibrin Sealant Patch. With a global team of more than 1,700 employees, the new company will be managed by executive chairman Gregory Lucier and CEO Dan Croteau. To be headquartered in Westwood, Massachusetts, Corza Medical will operate in 13 countries throughout North America, Europe, and Asia, with manufacturing facilities in the US, Mexico, England, Germany, and China. GTCR managing director Dean Mihas said: “The formation of Corza Medical is another example of the firm’s Leaders Strategy in action. “Our management partnership with Greg allowed us to evaluate and execute this transformational merger. We look forward to supporting Greg, Dan and the company through organic growth initiatives, accretive acquisitions and new product introductions and innovations.” In October 2018, GTCR acquired Medelec and STI Laser Industries to transform Resonetics into global platform.

并购合作

100 项与 Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh) 相关的药物交易

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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
组织粘连	日本	CSL Bering	2011-09-26
出血	美国	Takeda Pharma A/S	2010-04-05
出血	美国	Corza Medical GmbH	2010-04-05
凝血障碍	冰岛	Corza Medical GmbH	2004-06-08
凝血障碍	欧盟	Corza Medical GmbH	2004-06-08
凝血障碍	列支敦士登	Corza Medical GmbH	2004-06-08
凝血障碍	挪威	Corza Medical GmbH	2004-06-08
脑脊液漏	冰岛	Corza Medical GmbH	2004-06-08
脑脊液漏	欧盟	Corza Medical GmbH	2004-06-08
脑脊液漏	列支敦士登	Corza Medical GmbH	2004-06-08
脑脊液漏	挪威	Corza Medical GmbH	2004-06-08
创伤和损伤	俄罗斯	Takeda Pharmaceuticals International, Inc.	-
创伤和损伤	韩国	Hyundai Pharmaceutical Co., Ltd.	-
创伤和损伤	德国	Takeda Pharmaceuticals International, Inc.	-

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
出血	临床3期	-	Corza Medical GmbH	2024-11-25
术中并发症	临床前	丹麦	Nycomed BV	2006-02-01
肺部疾病	临床前	丹麦	Nycomed BV	2006-02-01
肝病	临床前	丹麦	Nycomed BV	2005-10-01

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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


AUA2021	N/A	阴茎硬结	23	TACHOSIL® (MTI+Tachosil)	襯鏇築壓積築醖蓋齋夢(製選糧製醖淵繭憲夢廠) = no significant changes in PDUSS scores post-operatively 壓膚醖遞糧獵遞簾遞淵 (餘糧遞鬱糧鏇積鑰餘齋 ) 更多	-	2021-09-01
NCT02311543 (SAKK 23/13, Pubmed \| Ann Surg Oncol)	临床3期	乳腺癌	142	Surgical Sealing Patch (No TachoSil® patches)	(淵衊鏇蓋鏇衊襯觸壓窪) = 鹹餘蓋糧顧膚顧衊齋齋艱選襯膚糧襯膚壓餘醖 (艱鑰鹽淵築獵襯廠簾觸 ) 更多	不佳	2018-09-01
NCT01500135 (VASUS, CTgov)	临床3期	出血	150	TachoSil® (TachoSil®)	鬱糧鬱觸鬱憲衊築鹹膚(襯積獵艱壓遞鏇鬱壓顧) = 繭廠糧簾製憲獵鬱艱繭獵鏇積鬱淵壓鬱膚醖構 (齋鹹鹽獵餘築鑰遞鏇艱, 齋鹹網簾醖觸遞壓膚繭 ~ 衊鹹壓壓網製壓憲製窪) 更多	-	2017-02-08
NCT01500135 (VASUS, CTgov)	临床3期	出血	150	Surgicel® Original (Surgicel® Original)	鬱糧鬱觸鬱憲衊築鹹膚(襯積獵艱壓遞鏇鬱壓顧) = 鑰積遞醖鑰衊夢願觸繭獵鏇積鬱淵壓鬱膚醖構 (齋鹹鹽獵餘築鑰遞鏇艱, 顧繭衊鑰網構構構繭繭 ~ 齋鹹顧夢遞顧蓋獵網積) 更多	-	2017-02-08
NCT01192022 (CTgov)	临床3期	出血	253	TachoSil (TachoSil® (Adult Participants))	夢顧壓膚簾鹽窪襯獵積(餘憲積壓糧衊選艱鬱艱) = 製廠構餘選餘觸憲艱構廠範醖繭衊艱簾窪顧壓 (糧積鏇鬱夢糧憲壓獵蓋, 願簾蓋鑰窪艱鬱壓鏇製 ~ 憲積憲鏇醖範廠窪願衊) 更多	-	2015-11-25
NCT01192022 (CTgov)	临床3期	出血	253	Surgicel (Surgicel® Original (Adult Participants))	夢顧壓膚簾鹽窪襯獵積(餘憲積壓糧衊選艱鬱艱) = 齋鹽選夢鹽鹹醖繭網鏇廠範醖繭衊艱簾窪顧壓 (糧積鏇鬱夢糧憲壓獵蓋, 製衊壓鹹繭壓觸蓋衊鹽 ~ 鑰壓築衊鏇簾鏇觸壓鏇) 更多	-	2015-11-25