Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)(Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited))

概要

基本信息

药物类型

重组凝血因子

别名

Factor I/factor IIa、Factor IIa/factor I、Fibrinogen/thrombin dry powder - Mallinckrodt

+ [7]

靶点-

作用方式-

作用机制-

治疗领域

血液及淋巴系统疾病其他疾病

在研适应症-

非在研适应症

凝血障碍出血术后出血

原研机构

Mallinckrodt Pharmaceuticals Ireland Ltd.

在研机构-

非在研机构

Mallinckrodt PlcMallinckrodt Pharmaceuticals Ireland Ltd.Mallinckrodt LLC

+ [1]

最高研发阶段撤市

首次获批日期

欧盟 (2015-03-19),

凝血障碍

最高研发阶段(中国)-

特殊审评-

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关联

6

项与 Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited) 相关的临床试验

NCT02117349

/ Terminated临床2期

A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population

The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.

开始日期2014-12-04

申办/合作机构

Mallinckrodt Plc

NCT02284256

/ Completed临床3期

A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical FibrocapsTM (RaplixaTM) and Tachosil® in Surgical Hemostasis During Hepatic Resection

The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.

开始日期2014-11-01

申办/合作机构

Mallinckrodt Plc

NCT01527357

/ Completed临床3期

A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.
The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.

开始日期2012-05-21

申办/合作机构

Mallinckrodt Plc

100 项与 Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited) 相关的临床结果

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100 项与 Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited) 相关的转化医学

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100 项与 Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited) 相关的专利（医药）

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6

项与 Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited) 相关的文献（医药）

2019-01-01·Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology4区 · 医学

Functional outcomes after glossectomies: Pilot study on use of a thrombin-fibrinogen biosponge (TachoSil)

4区 · 医学

Article

作者: Sieira-Gil, Ramón ; Pozuelo-Arquimbau, Laura ; Arranz-Obispo, Carlos D ; Cuesta-González, Francisco J ; Marí-Roig, Antoni

OBJECTIVEThe aim of this study was to investigate whether the use of a thrombin-fibrinogen biosponge (TachoSil) has any advantage in tongue healing.STUDY DESIGNA retrospective study with 30 patients treated with partial glossectomy (below half a tongue) was designed. We compared the results from a group using the biosponge (n =15 patients) and a control group (n = 15). Variables taken into consideration were bolus clearance, frenulum flexibility, and oral transit time. With these parameters, we formulated a "tongue remaining functional" (TRF) scale to assess tongue functionality after the surgery. We also evaluated long-term quality of life by using the Functional Intraoral Glasgow Scale (FIGS).RESULTSIn this study, TRF score, bolus clearance, oral transit time, and frenulum flexibility were significantly improved in the biosponge group. However, there were no differences between the 2 groups in the FIGS scores.CONCLUSIONSThe use of the biosponge in this pilot study showed positive long-term effects in lingual healing and functionality after partial glossectomies.

2015-11-01·Journal of Vascular Surgery2区 · 医学

Randomized trial of a dry-powder, fibrin sealant in vascular procedures

2区 · 医学

Article

作者: Moneta, Gregory L ; Gupta, NavYash ; Hayes, Paul ; Pribble, John P ; Zuckerman, Linda A ; Chetter, Ian ; O-Yurvati, Albert H ; Shenoy, Surendra

OBJECTIVETopical hemostats are important adjuncts for stopping surgical bleeding. The safety and efficacy of Fibrocaps, a dry-powder, fibrin sealant containing human plasma-derived thrombin and fibrinogen, was evaluated in patients undergoing vascular surgical procedures.METHODSIn this single-blind trial (clinicaltrials.gov: NCT01527357), adult patients were randomized 2:1 to Fibrocaps plus gelatin sponge (Fibrocaps) vs gelatin sponge alone. Results are presented for the patient subset undergoing vascular procedures with suture hole bleeding. The primary efficacy endpoint compared time to hemostasis (TTH) over 5 minutes. Safety follow-up continued to day 29.RESULTSA total of 175 patients were randomized and treated (Fibrocaps, 117; gelatin sponge, 58). Patients were predominately male (69%) and underwent arterial bypass (81%), arteriovenous graft formation (9%), or carotid endarterectomy (9%). Fibrocaps significantly reduced TTH compared with gelatin sponge (hazard ratio [HR], 2.1; 95% confidence interval [CI], 1.5-3.1; median TTH, 2 minutes; 95% CI, 1.5-2.5 vs 4 minutes; 95% CI, 3.0-5.0; P < .002). Significant reductions were also observed in patients receiving concomitant antiplatelet agents alone (HR, 2.8; 95% CI, 1.0-7.4; P = .03; n = 33), anticoagulants alone (HR, 2.0; 95% CI, 1.0-4.0; P = .04; n = 43), or both antiplatelet agents and anticoagulants (Fibrocaps vs gelatin sponge, HR, 2.3; 95% CI, 1.2-4.3; P = .008; n = 65). Incidences of common adverse events (procedural pain, nausea, constipation) were generally comparable between treatment arms. Anti-thrombin antibodies developed in 2% of Fibrocaps-treated patients and no-gelatin-sponge patients.CONCLUSIONSFibrocaps, a ready-to-use, dry-powder fibrin sealant, was well-tolerated and reduced TTH in patients undergoing vascular procedures, including those receiving antiplatelet agents and/or anticoagulants, demonstrating its safety and usefulness as an adjunct to hemostasis.

2015-08-01·Clinical Drug Investigation

Raplixa™: A Review in Improving Surgical Haemostasis

Review

作者: McKeage, Kate

Raplixa™ is a novel fibrin sealant containing a blend of human fibrinogen and thrombin in powder form. It is approved in adults to help control bleeding when standard surgical techniques have been insufficient. This article summarizes the product characteristics of Raplixa and provides a narrative review of its clinical use and tolerability. Unlike other available fibrin sealants, including liquid agents and lyophilized powders, the dry-powder, ready-to-use formulation of Raplixa provides potential advantages, including ease of storage and use. In the randomized, phase III FINISH-3 study, Raplixa plus gelatin sponge was superior to gelatin sponge alone in reducing the time to haemostasis in adults who developed mild or moderate bleeding uncontrolled by conventional surgical techniques while undergoing spinal, vascular, hepatic or soft-tissue surgical procedures. Raplixa was well tolerated, with a similar safety profile to that observed in the gelatin-sponge-alone group. Thus, Raplixa provides an easy to store and use option for improving haemostasis in adults when standard surgical techniques are ineffective or impractical.

1

项与 Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited) 相关的新闻（医药）

2023-11-02

·BioSpace

Endeavor BioMedicines Appoints Paul Frohna, M.D., Ph.D., as Chief Medical Officer

SAN DIEGO--(BUSINESS WIRE)-- Endeavor BioMedicines, a clinical-stage company developing therapies for of fibrotic disease and oncology, today announced the appointment of Paul Frohna, M.D., Ph.D., as its Chief Medical Officer. Dr. Frohna is a physician-scientist with over 20 years of experience in the biotech industry in the fields of translational medicine, clinical trial design, and clinical and regulatory strategy. “We’re pleased to welcome Paul as our Chief Medical Officer, and we look forward to his leadership as we progress our pipeline of therapies for patients with fibrosis and cancer,” said John Hood, Ph.D., Co-Founder, CEO and Chairman, Endeavor BioMedicines. “Paul’s deep experience as a physician-scientist and impressive track record in clinical development and translational medicine will be valuable additions to Endeavor as we advance our programs, including our Phase 2 trial of ENV-101 in idiopathic pulmonary fibrosis (IPF) and the first-in-human trial for our HER3-targeted ADC in oncology.” Dr. Frohna joins Endeavor from ImCheck Therapeutics in Marseille, France, where he served as Chief Medical Officer and Head of Research and Development responsible for overseeing programs in oncology and infectious disease. Prior to ImCheck, he was Chief Medical Officer at Bioniz Therapeutics, where he led clinical and regulatory affairs functions and was responsible for operational oversight of the company's clinical programs in T-cell leukemia and lymphoma as well as autoimmune diseases. Prior to this role, he held senior roles at Receptos Inc., ProFibrix, Inc. and Fibrogen. Dr. Frohna began his biotech career at Genentech where he patented and initially tested the therapeutic approach of B-cell depleting therapy for relapsing and progressive multiple sclerosis. “It is a privilege to join Endeavor as the company enters its next stage of growth," said Dr. Frohna. “I look forward to contributing my clinical development experiences in fibrosis and oncology to demonstrate the therapeutic promise of our pipeline of medicines in order to help patients who deserve better treatments for their deadly diseases.” Over the course of his career, Dr. Frohna has built and led departments and teams responsible for candidate selection, IND/CTA filings, Phase I to III clinical trials and global development partnerships. He has successfully designed and initiated translational and clinical programs for biologics, small molecules and stem cells across multiple therapeutic areas. He played critical roles in multiple development programs including Receptos' ozanimod (Zeposia® marketed by BMS), Profibrix’s Raplixa™ and Genentech's Rituxan®, Tarceva® and Raptiva® programs. Dr. Frohna received his pharmacy degree from the University of Texas at Austin College of Pharmacy, his Ph.D. in Pharmacology from the University of Pennsylvania School of Medicine, and his M.D. from Georgetown University School of Medicine. About Endeavor BioMedicines Endeavor BioMedicines, Inc., is a clinical stage company developing novel therapies for fibrosis and oncology. We combine best-in-class therapeutics with an evolved understanding of terminal diseases to develop medicines with the potential to reverse severe health conditions. Our lead program, ENV-101, is a Hedgehog signalling inhibitor currently in Phase 2 studies treating IPF. The second program is a HER3-targeted ADC that will begin clinical development in 2024 for the treatment of multiple solid tumors. At Endeavor, we are an innovative and focused team that has come together to develop therapeutics that help patients feel better and live longer. Please visit us on our website at and on our LinkedIn and X (formerly Twitter) pages. View source version on businesswire.com: Contacts Will Zasadny Evoke Canale Will.zasadny@evokegroup.com Source: Endeavor BioMedicines View this news release online at:

临床2期高管变更临床1期

100 项与 Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	B02BC30	-

研发状态

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
术后出血	临床1期	美国	Mallinckrodt Plc	2012-05-21
术后出血	临床1期	荷兰	Mallinckrodt Plc	2012-05-21
术后出血	临床1期	英国	Mallinckrodt Plc	2012-05-21
术后出血	临床1期	比利时	Mallinckrodt Plc	2012-05-21

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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


NCT02117349 (CTgov)	临床2期	术后出血	55	Gelfoam+Raplixa	糧廠糧襯鹹鑰夢網網築(壓鹽齋顧獵網構製淵蓋) = 膚鹽餘鏇繭構築簾艱構窪壓艱選鹹憲鏇製餘鏇 (廠願顧餘鹹顧積範簾鬱, 鬱觸膚衊製膚廠夢築鏇 ~ 構膚廠獵繭願醖齋顧構) 更多	-	2020-02-05
NCT01527357 (FINISH-3, CTgov)	临床3期	术后出血	721	Gelatin sponge+Fibrocaps (Fibrocaps + Gelatin Sponge)	獵夢築網繭鏇獵壓廠願(遞觸構製網網積觸網廠) = 簾簾鏇鏇顧糧齋襯積壓膚鑰衊醖醖醖夢積醖鏇 (觸膚襯壓衊糧艱衊膚繭, 築醖廠夢淵觸觸蓋顧壓 ~ 憲製簾鑰鏇窪網糧觸醖) 更多	-	2019-12-18
				Gelatin sponge (Gelatin Sponge)	獵夢築網繭鏇獵壓廠願(遞觸構製網網積觸網廠) = 構築顧壓襯襯築簾窪鬱膚鑰衊醖醖醖夢積醖鏇 (觸膚襯壓衊糧艱衊膚繭, 糧憲範構築製醖襯襯醖 ~ 範製網築積構遞廠願廠) 更多
NCT01256190 (CTgov)	临床2期	术后出血	56	Gelatin sponge+Fibrocaps (fibrin sealant) (Fibrocaps + Gelatin Sponge)	夢鹹蓋鏇願選醖遞蓋餘(鏇積鬱鏇鹹鏇齋艱獵鏇) = 簾選淵鹹艱鏇憲選餘齋築願壓網築積鹹鏇鹽簾 (鏇鹽淵壓廠鑰繭廠齋鏇, 廠範憲獵糧鹹願醖窪鏇 ~ 衊夢鏇衊繭蓋鏇膚衊繭) 更多	-	2014-05-15
				Gelatin sponge (Gelatin Sponge)	夢鹹蓋鏇願選醖遞蓋餘(鏇積鬱鏇鹹鏇齋艱獵鏇) = 鹹鑰衊積蓋衊蓋淵淵選築願壓網築積鹹鏇鹽簾 (鏇鹽淵壓廠鑰繭廠齋鏇, 顧鬱糧衊簾觸構顧夢壓 ~ 鏇憲網鹽獵簾願鏇夢繭) 更多