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.

Start Date04 Dec 2014

Sponsor / Collaborator

Mallinckrodt Plc

NCT02284256 / CompletedPhase 3

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.

Start Date01 Nov 2014

Sponsor / Collaborator

Mallinckrodt Plc

NCT01527357 / CompletedPhase 3

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.

Start Date21 May 2012

Sponsor / Collaborator

Mallinckrodt Plc

100 Clinical Results associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

100 Translational Medicine associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

100 Patents (Medical) associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

Literatures (Medical) associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

01 Sep 2019·Critical Pathways in Cardiology: A Journal of Evidence-Based Medicine

Management of Severe Bleeding in Patients Treated With Oral Anticoagulants

Review

Author: Roat, Todd W. ; Hirsch, Amy L. ; Gibler, W. Brian ; Racadio, Judy M.

In this Emergency Medicine Cardiac Research and Education Group (EMCREG)-International Proceedings Monograph from the October 20, 2018, EMCREG-International Multidisciplinary Consensus Panel on Management of Severe Bleeding in Patients Treated With Oral Anticoagulants held in Orlando, FL, you will find a detailed discussion regarding the treatment of patients requiring anticoagulation and the reversal of anticoagulation for patients with severe bleeding. For emergency physicians, critical care physicians, hospitalists, cardiologists, internists, surgeons, and family physicians, the current approach and disease indications for treatment with anticoagulants such as coumadin, factor IIa, and factor Xa inhibitors are particularly relevant. When a patient treated with anticoagulants presents to the emergency department, intensive care unit, or operating room with severe, uncontrollable bleeding, achieving rapid, controlled hemostasis is critically important to save the patient’s life. This EMCREG-International Proceedings Monograph contains multiple sections reflecting critical input from experts in Emergency Cardiovascular Care, Prehospital Emergency Medical Services, Emergency Medicine Operations, Hematology, Hospital Medicine, Neurocritical Care, Cardiovascular Critical Care, Cardiac Electrophysiology, Cardiology, Trauma and Acute Care Surgery, and Pharmacy. The first section provides a description of the current indications for the treatment of patients using oral anticoagulants including coumadin, the factor IIa (thrombin) inhibitor dabigatran, and factor Xa inhibitors such as apixaban and rivaroxaban. In the remaining sections, the treatment of patients presenting to the hospital with major bleeding becomes the focus. The replacement of blood components including red blood cells, platelets, and clotting factors is the critically important initial treatment for these individuals. Reversing the anticoagulated state is also necessary. For patients treated with coumadin, infusion of vitamin K helps to initiate the process of protein synthesis for the vitamin K–dependent coagulation proteins II, VII, IX, and X and the antithrombotic protein C and protein S. Repletion of clotting factors for the patient with 4-factor prothrombin complex concentrate, which includes factors II (prothrombin), VII, IX, and X and therapeutically effective concentrations of the regulatory proteins (protein C and S), provides real-time ability to slow bleeding. For patients treated with the thrombin inhibitor dabigatran, treatment using the highly specific, antibody-derived idarucizumab has been demonstrated to reverse the hypocoagulable state of the patient to allow blood clotting. In May 2018, andexanet alfa was approved by the US Food and Drug Administration to reverse the factor Xa anticoagulants apixaban and rivaroxaban in patients with major bleeding. Before the availability of this highly specific agent, therapy for patients treated with factor Xa inhibitors presenting with severe bleeding usually included replacement of lost blood components including red blood cells, platelets, and clotting factors and 4-factor prothrombin complex concentrate, or if not available, fresh frozen plasma. The evaluation and treatment of the patient with severe bleeding as a complication of oral anticoagulant therapy are discussed from the viewpoint of the emergency physician, neurocritical and cardiovascular critical care intensivist, hematologist, trauma and acute care surgeon, hospitalist, cardiologist, electrophysiologist, and pharmacist in an approach we hope that the reader will find extremely practical and clinically useful. The clinician learner will also find the discussion of the resumption of oral anticoagulation for the patient with severe bleeding after effective treatment important because returning the patient to an anticoagulated state as soon as feasible and safe prevents thrombotic complications. Finally, an EMCREG-International Severe Bleeding Consensus Panel algorithm for the approach to management of patients with life-threatening oral anticoagulant–associated bleeding is provided for the clinician and can be expanded in size for use in a treatment area such as the emergency department or critical care unit.

01 Jan 2019·Oral Surgery, Oral Medicine, Oral Pathology and Oral RadiologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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.

01 Nov 2015·Journal of Vascular SurgeryQ2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: 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.

News (Medical) associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

02 Nov 2023

·www.biospace.com

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:

Phase 2Executive ChangePhase 1

100 Deals associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

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Indication	Highest Phase	Country/Location	Organization	Date
Postoperative Hemorrhage	Preclinical	NL	Mallinckrodt Plc	21 May 2012
Postoperative Hemorrhage	Preclinical	GB	Mallinckrodt Plc	21 May 2012
Postoperative Hemorrhage	Preclinical	BE	Mallinckrodt Plc	21 May 2012
Postoperative Hemorrhage	Preclinical	US	Mallinckrodt Plc	21 May 2012

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02117349 (CTgov)	Phase 2	Postoperative Hemorrhage	55	Gelfoam+Raplixa	pgrgxjngrp(rhtpqfwgcd) = kvhtifavnv bsbpttnzme (tildveabuz, abntbbqcks - pyhcmgppjn) View more	-	05 Feb 2020
NCT01527357 (FINISH-3, CTgov)	Phase 3	Postoperative Hemorrhage	721	Gelatin sponge+Fibrocaps (Fibrocaps + Gelatin Sponge)	rbpjniavsh(ehqdrvvbyv) = kaluhvctgn pjdyiztoba (xfkgqcawhw, qxzksoqiyq - hafusgnlpb) View more	-	18 Dec 2019
				Gelatin sponge (Gelatin Sponge)	rbpjniavsh(ehqdrvvbyv) = odzcgpexeh pjdyiztoba (xfkgqcawhw, eamvissklg - cixptuhrlk) View more
NCT01256190 (CTgov)	Phase 2	Postoperative Hemorrhage	56	Gelatin sponge+Fibrocaps (fibrin sealant) (Fibrocaps + Gelatin Sponge)	dvfupdmbpa(orwsnxcxhf) = fwlxkqgbxz hociwdbogd (xjhybgywzf, utgiimbuau - cnbgfqjjqz) View more	-	15 May 2014
				Gelatin sponge (Gelatin Sponge)	dvfupdmbpa(orwsnxcxhf) = wxdamjdokf hociwdbogd (xjhybgywzf, bwjxzusznk - izgyhgiafk) View more

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