(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 (Takeda)、Fibrin Sealant Patch, Absorbable(Takeda Pharma)、human fibrinogen / human thrombin(Takeda Pharmaceuticals International GmbH)

+ [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 MedicalTakeda 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

43

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

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

NCT05717335 / CompletedN/AIIT

Observational Pilot Study With TachoSil as a Ventricular Sealant

The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.
A more specific hypothesis is that the use of Tachosil for brain surgery with ventricular entry reduces the number of postoperative complications (hydrocephalus, CSF leak, meningitis and pseudomeningocele).

开始日期2022-05-01

申办/合作机构

Germans Trias i Pujol Hospital

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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356

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

2024-03-01·American journal of surgery

Pancreatic stump closure after distal pancreatectomy: Systematic review and meta-analysis of randomized clinical trials comparing non-autologous versus no reinforcement: Value of prediction intervals

Review

作者: Chaouch, Mohamed Ali ; Dziri, Chadli ; Uranues, Selman ; Fingerhut, Abe

BACKGROUND:

This meta-analysis of randomized trials aimed to assess the benefits and harms of non-autologous versus no reinforcement of the pancreatic stump following distal pancreatectomy (DP).

METHODS:

It was performed in accordance with PRISMA 2020 and AMSTAR 2 Guidelines. (registered in PROSPERO ID: EROCRD42021286863).

RESULTS:

Nine relevant articles (between 2009 and 2021) were retrieved, comparing non-autologous reinforcement (757 patients) with non-reinforcement (740 patients) after PD. Pooled analysis showed a statistically significant lower rate of postoperative pancreatic fistula (POPF) in the reinforcement group (RR = 0.677; 95 % CI [0.479, 0.956], p = 0.027). The 95 % predictive interval (0.267-1.718) showed heterogeneity. Non-autologous reinforcement other than with "Tachosil®" was effective (subgroup analysis). No statistically significant differences were found between the two groups with regard to secondary outcomes.

CONCLUSIONS:

This meta-analysis showed that covering the stump with non-autologous reinforcement other than Tachosil® had a preventive effect on the onset of POPF.

2023-11-01·Operative neurosurgery (Hagerstown, Md.)

Validation of Efficacy and Safety of TachoSil ® Tissue Sealant for Vessel Transposition in Microvascular Decompression.

Article

作者: Numazawa, Shinichi ; Toyooka, Terushige ; Morita, Shuhei ; Otani, Naoki ; Wada, Kojiro ; Mori, Kentaro ; Watanabe, Sadayoshi

BACKGROUND AND OBJECTIVES:

Use of TachoSil ® as the transposition material of microvascular decompression (MVD) for hemifacial spasm (HFS) and trigeminal neuralgia (TN) is easy and safe to perform, but the efficacy and safety of this technique are unknown. This study attempted to validate the efficacy and safety of TachoSil ® as a transposition material of MVD.

METHODS:

A retrospective study of the surgical results and complications of 63 patients (35 HFS and 28 TN) treated by the TachoSil ® technique between January 2011 and December 2021 was conducted. The efficacy of the treatment was evaluated by Kaplan-Meier survival analysis. Magnetic resonance imaging follow-up study was performed to detect any adverse events including a mass formation.

RESULTS:

The rate of complete disappearance of HFS was 91.4% at 1 year and estimated to be 85.7% after a 10-year follow-up. The rate of no pain without medication for TN was 85.4% at 1 year and estimated to be 69.0% after a 9-year follow-up. These surgical results are comparable with those previously reported. Flaking of TachoSil ® releasing the offending artery was only recognized in one case (1.6%). Therefore, TachoSil ® can be considered as an effective transposition material for MVD. TachoSil ® did not increase the rate of acute and subacute adverse events such as inflammation and delayed facial palsy. Magnetic resonance imaging follow-up identified no abnormalities including mass that suggested granuloma formation.

CONCLUSION:

The efficacy of the TachoSil ® technique for HFS and TN and the reliability of TachoSil ® as an adhesive material in MVD were verified. No adverse events associated with TachoSil ® use in MVD were found. We conclude that the TachoSil ® technique has relatively long efficacy and safety for MVD.

2023-10-01·Journal of thoracic disease

Which bioabsorbable sheet is optimal for combined application with fibrin sealant against alveolar air leakage?

Article

作者: Itano, Hideki

Background:

There are few basic comparative data on the sealing effect of various bioabsorbable sheets in combination with fibrin sealant (FS), which is a more effective tool for the control of alveolar air leakage than the single use of FS alone. The objective of this study was to investigate which bioabsorbable sheet had the best sealing effect against alveolar air leakage when used in combination with FS, in terms of material quality, weaving pattern, and/or thickness.

Methods:

Standardized 20 mm × 30 mm pleural defects were covered with three pieces of the following sheets using the Rub + Soak B technique in an ex vivo porcine lung model. Seal-breaking burst pressure (SBBP) was compared between groups. Experiment 1: 0.15 mm-thick (Group 1), 0.3 mm-thick (Group 2) and 0.5 mm-thick (Group 3) non-woven polyglycolic acid (PGA) felt were compared. Experiment 2: 0.15 mm-thick non-woven PGA felt (Group 1), 0.15 mm-thick meshed oxidised regenerated cellulose (ORC) (Group 4); 0.11 mm-thick woven PGA (Group 5) and 0.18 mm-thick knitted PGA (Group 6) were compared. Experiment 3: TachoSil^® alone (Group 7), TachoSil^® combined with FS (Group 8) and 0.15 mm-thick non-woven PGA felt (1 piece) (Group 9) were compared.

Results:

In Experiment 1, SBBP was significantly higher in Group 1 than in Group 3. The SBBP in Group 2 was significantly higher than that in Group 3. In Experiment 2, SBBP in Group 4 was significantly lower than that in Groups 1, 5, and 6. In Experiment 3, SBBP in Group 7 was significantly lower than that in Groups 8 and 9.

Conclusions:

Regarding the sheet thickness of PGA felt, the 0.15 mm was the most effective. Regarding the material quality, the ORC was the least suitable. TachoSil^® combined with FS was comparable to the most effective 0.15 mm-thick non-woven PGA felt.

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	2010-04-05
凝血障碍	欧盟	Corza Medical	2004-06-08
凝血障碍	冰岛	Corza Medical	2004-06-08
凝血障碍	列支敦士登	Corza Medical	2004-06-08
凝血障碍	挪威	Corza Medical	2004-06-08
脑脊液漏	欧盟	Corza Medical	2004-06-08
脑脊液漏	冰岛	Corza Medical	2004-06-08
脑脊液漏	列支敦士登	Corza Medical	2004-06-08
脑脊液漏	挪威	Corza Medical	2004-06-08
创伤和损伤	奥地利	Takeda Pharmaceuticals International, Inc.	1992-12-31

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
术中并发症	临床3期	丹麦	Nycomed BV	2006-02-01
肺部疾病	临床3期	丹麦	Nycomed BV	2006-02-01
肝病	临床3期	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)	顧鬱鏇襯夢糧積構餘艱(艱餘壓構餘願窪糧夢夢) = no significant changes in PDUSS scores post-operatively 遞築範膚淵齋構淵壓願 (遞壓餘網憲範鑰夢廠齋 ) 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)	簾淵簾積鬱窪選獵簾獵(鏇廠鹽餘鹹選簾衊積鏇) = 鏇願窪遞淵壓獵繭艱鹹鑰積觸製齋選製艱網積 (窪願製鏇憲鬱獵簾膚構 ) 更多	不佳	2018-09-01
NCT01500135 (CTgov)	临床3期	出血	150	TachoSil® (TachoSil®)	築窪製齋製淵簾獵簾製(餘夢壓積鏇鑰願壓壓夢) = 糧繭蓋願觸鏇糧鑰築鹽積糧鏇遞網憲窪鏇窪構 (衊糧壓廠鏇糧選齋鏇繭, 範範憲餘淵艱願糧醖選 ~ 窪構獵鏇網淵餘壓獵獵) 更多	-	2017-02-08
				Surgicel® Original (Surgicel® Original)	築窪製齋製淵簾獵簾製(餘夢壓積鏇鑰願壓壓夢) = 糧構廠簾夢齋糧鬱選製積糧鏇遞網憲窪鏇窪構 (衊糧壓廠鏇糧選齋鏇繭, 網積憲衊衊鬱願醖繭襯 ~ 獵遞範顧鹹觸壓簾觸積) 更多
NCT01192022 (CTgov)	临床3期	出血	253	TachoSil (TachoSil® (Adult Participants))	窪壓糧糧鏇鏇衊積襯鏇(憲齋窪築觸觸憲構遞獵) = 憲夢蓋壓鑰蓋獵夢窪淵簾遞艱蓋積衊鑰糧鏇蓋 (夢齋壓鑰襯鹹鑰願鹹齋, 廠遞鹹範選獵糧壓餘衊 ~ 顧選壓觸夢積廠窪淵糧) 更多	-	2015-11-25
				Surgicel (Surgicel® Original (Adult Participants))	窪壓糧糧鏇鏇衊積襯鏇(憲齋窪築觸觸憲構遞獵) = 構餘鑰鹽鹹築淵鹹網選簾遞艱蓋積衊鑰糧鏇蓋 (夢齋壓鑰襯鹹鑰願鹹齋, 簾艱糧憲齋糧壓鑰範鑰 ~ 鏇網願鹽鏇範鏇憲蓋夢) 更多
NCT00440401 (TC-023-IM, CTgov)	临床4期	出血 \| 心血管疾病	120	fibrinogen (human) + thrombin (human) (TachoSil®)	窪齋簾壓鑰選壓鏇鏇範(範鬱醖選鹽鏇製淵艱鹹) = 製糧淵積餘繭鹽夢鬱壓壓獵構膚鏇淵壓鹽網淵 (顧積鹽膚願鹽鑰窪範顧, 窪憲鹹積願構顧顧繭壓 ~ 遞構蓋遞壓觸壓網衊膚) 更多	-	2010-06-04
				Standard haemostatic treatment in cardiovascular surgery (Standard Treatment)	窪齋簾壓鑰選壓鏇鏇範(範鬱醖選鹽鏇製淵艱鹹) = 積壓齋積齋壓衊夢顧鏇壓獵構膚鏇淵壓鹽網淵 (顧積鹽膚願鹽鑰窪範顧, 製製遞繭憲網鏇構糧獵 ~ 艱淵糧築顧積鏇繭夢窪) 更多