Drugs / Fibrinogen Concentrate Human
last change Jun 2026 re-read 2 minutes ago

Fibrinogen Concentrate Human

Protein / enzyme biologic

Developed for
hemorrhagic disease · congenital afibrinogenemia · blood coagulation disease · acquired coagulation factor deficiency · melanoma · osteoarthritis, knee · vascular hemostatic disease · cerebrospinal fluid leak
+42 more · coagulation protein disease · congenital heart disease · aortic disorder · blood platelet disease · chronic pain syndrome · cleft palate · congenital fibrinogen deficiency · corneal ulcer · craniofacial and skeletal defects · digestive system disorder · esophageal varices · esophageal varices with bleeding · eyelid disorder · fibrinolytic defect · gastrocutaneous syndrome · heart valve disorder · infectious disease with sepsis · intracerebral hemorrhage · ischemic stroke · liver disorder · lymphedema · periodontitis · peripheral nerve lesion · peripheral vascular disease · pterygium · scoliosis · traumatic brain injury · anal fistula · aortic aneurysm · bile duct disorder · brain injury · cardiac valvular defect · cardiovascular disorder · chronic ulcer of skin · intestinal fistula · intestinal perforation · lymphocele · neuropathy, painful · rotator cuff syndrome · urinary tract obstruction · vascular insufficiency disorder · vertebral column disorder
Investigated by
CSL Behring · Ethicon, Inc. · Baxter Healthcare Corporation · Mallinckrodt · Grifols, S.A. · OMRIX Biopharmaceuticals
+106 more · Sant Pau Research Institute · Australian Red Cross · Biotest · Blood and Tissue Bank of Catalonia · Emergency Medicine Foundation · Emory University · Gold Coast Hospital and Health Service · LFB · M.D. Anderson Cancer Center · National Blood Authority · Nycomed · Octapharma · Sahlgrenska University Hospital · Aase and Ejnar Danielsens Foundation · Accovion GmbH · Angel Augusto Perez Calatayud · Antoni Sabaté Pes · Asan Medical Center · Australasian College for Emergency Medicine · Australasian Trauma Society · Australian Red Cross Lifeblood · Australian and New Zealand Intensive Care Research Centre · Australian and New Zealand Intensive Care Society Clinical Trials Group · Azienda Usl di Bologna · Baxter Innovations GmbH · Bayer · Beijing Anzhen Hospital · Blood Bank of the Danish capital region · Blood Synergy Program · Brno University Hospital · Centre Hospitalier Universitaire, Amiens · Chhattisgarh Dental College and Research Institute · Copenhagen University Hospital at Herlev · Copenhagen University Hospital, Hvidovre · Cristina Martinez · Danish Council for Independent Research · Duke University · Fonden til Lægevidenskabens Fremme · Grifols Therapeutics LLC · Grupo Mexicano para el Estudio de la Medicina Intensiva · Gynecologic Oncology Group · Haemonetics Corporation · Hans og Nora Buchards Fond · Helsinki University Central Hospital · Herlev Hospital · Hillerod Hospital, Denmark · Hobart Harris · Hongjia Zhang · Hospital Universitari de Bellvitge · ICON Clinical Research · ICON plc · IRCCS Policlinico S. Donato · Insel Gruppe AG, University Hospital Bern · Institut de Cancérologie de la Loire · Isala · Laerdal Foundation · Leila Dehghani · MDM · Massachusetts General Hospital · Mayo Clinic · Medical University Innsbruck · Medical University of South Carolina · Ministero della Salute, Italy · Montreal Children's Hospital of the MUHC · NHS Lothian · National Cancer Institute (NCI) · National Taiwan University Hospital · OHSU Knight Cancer Institute · Oregon Health and Science University · Oxford University Hospitals NHS Trust · PRA Health Sciences · Pauza, Kevin, MD · Peking Union Medical College Hospital · Phoenix Clinical Research · all 112 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) TachoSil 2004-06-08 europa.eu

Trials 86 · started per year

today
EU approved 2004
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2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT04664738 Mar 2021 → Aug 2023 Rion Inc. Unknown No outcome recorded
Phase 1 NCT02584153 Jan → Dec 2019 Hobart Harris Withdrawn No outcome recorded
Phase 1 NCT00155402 Apr 2005 → Mar 2008 corneal ulcer, pterygium National Taiwan University Hospital Withdrawn No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT02528708 Jan → Dec 2021 Yale University Withdrawn No outcome recorded
Phase 1/2 NCT03780894 Nov 2018 → Jan 2021 Blood and Tissue Bank of Catalonia Completed No outcome recorded
Phase 1/2 NCT03304899 Oct 2018 → Dec 2019 hemorrhagic disease, traumatic brain injury Leila Dehghani Unknown No outcome recorded
Phase 1/2 NCT02281500 Jul 2016 → Nov 2019 congenital afibrinogenemia Grifols Therapeutics LLC Completed No outcome recorded
Phase 1/2 NCT00161759 Mar 2002 → Jan 2004 Baxter Healthcare Corporation Completed No outcome recorded
Phase 215 trials
Phase 2 NCT05091684 Feb 2022 → May 2023 blood platelet disease, hemorrhagic disease University Hospital of Saint-Etienne Terminated No outcome recorded
Phase 2 NCT04434001 Feb 2020 → May 2021 acquired coagulation factor deficiency, acute lung injury, congenital heart disease, hemorrhagic disease IRCCS Policlinico S. Donato Terminated No outcome recorded
Phase 2 NCT03508141 Jul 2018 → Jun 2021 blood coagulation disease, hemorrhagic disease Gold Coast Hospital and Health Service Unknown No outcome recorded
Phase 2 NCT04807621 Mar 2018 → Jan 2022 congenital heart disease Sahlgrenska University Hospital Unknown No outcome recorded
Phase 2 NCT02745041 Dec 2016 → Jan 2018 blood coagulation disease, hemorrhagic disease Gold Coast Hospital and Health Service Completed No outcome recorded
Phase 2 NCT02117349 Dec 2014 → Nov 2017 Mallinckrodt Terminated No outcome recorded
Phase 2 NCT02542306 Jul 2013 → Aug 2016 aortic disorder Hongjia Zhang Unknown No outcome recorded
Phase 2 NCT01575756 Jun 2013 → Jan 2015 congenital afibrinogenemia Octapharma Completed No outcome recorded
Phase 2 NCT01589822 Jun 2012 → Jan 2014 digestive system disorder Ethicon, Inc. Completed No outcome recorded
Phase 2 NCT01283321 Jan 2011 → May 2013 coronary artery disorder, heart valve disorder Emory University Terminated No outcome recorded
Phase 2/36 trials
Phase 2/3 NCT05358977 May 2022 → May 2023 eyelid disorder, ptosis University of Calgary Unknown No outcome recorded
Phase 2/3 NCT04621799 Jun 2018 → Dec 2020 lumbar disk degenerative disorder, lumbar disk disease, radiculopathy Pauza, Kevin, MD Unknown No outcome recorded
Phase 2/3 NCT02094430 Jan 2014 → Dec 2015 congenital afibrinogenemia LFB Completed No outcome recorded
Phase 2/3 NCT01359878 May 2011 → May 2013 Copenhagen University Hospital at Herlev Completed No outcome recorded
Phase 2/3 NCT01124981 Feb 2011 → Dec 2014 coagulation protein disease Isala Completed No outcome recorded
Phase 2/3 NCT01174992 Jul 2010 → Sep 2011 craniofacial and skeletal defects Ethicon, Inc. Completed No outcome recorded
Phase 325 trials
Phase 3 NCT04636268 Dec 2023 → Mar 2025 congenital afibrinogenemia Grifols, S.A. Withdrawn No outcome recorded
Phase 3 NCT05449834 Nov 2022 → Jun 2026 overdue blood coagulation disease Australian and New Zealand Intensive Care Research Centre Recruiting No outcome recorded
Phase 3 NCT05300672 Feb 2022 → Dec 2024 intracerebral hemorrhage, ischemic stroke Azienda Usl di Bologna Completed No outcome recorded
Phase 3 NCT03932240 Aug 2019 → Apr 2021 vascular hemostatic disease Emory University Completed No outcome recorded
Phase 3 NCT04111822 Oct 2018 → Oct 2020 infectious disease with sepsis Cristina Martinez Completed No outcome recorded
Phase 3 NCT03444324 Apr 2018 → Sep 2023 coagulation protein disease Biotest Completed No outcome recorded
Phase 3 NCT02457546 Jul 2015 → Sep 2017 cerebrospinal fluid leak Ethicon, Inc. Completed No outcome recorded
Phase 3 NCT02284256 Nov 2014 → Aug 2015 Mallinckrodt Completed No outcome recorded
Phase 3 NCT02309645 Oct 2014 → Aug 2021 cerebrospinal fluid leak Ethicon, Inc. Terminated No outcome recorded
Phase 3 NCT02227706 Aug 2014 → Apr 2019 hemorrhagic disease Ethicon, Inc. Completed No outcome recorded
Phase 419 trials
Phase 4 NCT07455591 Jan → Aug 2024 osteoarthritis, knee Singapore General Hospital Completed No outcome recorded
Phase 4 NCT05391412 Jun 2022 → Jul 2023 disseminated intravascular coagulation, hemorrhagic disease, scoliosis Brno University Hospital Unknown No outcome recorded
Phase 4 NCT04376762 Oct 2021 → Mar 2023 hemorrhagic disease, juvenile Huntington disease University of Virginia Completed No outcome recorded
Phase 4 NCT02953145 Sep 2019 → Sep 2020 cleft palate University of Alberta Withdrawn No outcome recorded
Phase 4 NCT04405518 Jun 2019 → Nov 2021 fibrinolytic defect Antoni Sabaté Pes Unknown No outcome recorded
Phase 4 NCT03920306 Apr 2019 → Sep 2024 gastrocutaneous syndrome University of British Columbia Completed No outcome recorded
Phase 4 NCT03183479 Jun 2017 → Aug 2019 adolescent idiopathic scoliosis, hemorrhagic disease Peking Union Medical College Hospital Completed No outcome recorded
Phase 4 NCT02864875 Dec 2015 → Jan 2017 acquired coagulation factor deficiency University of Sao Paulo General Hospital Completed No outcome recorded
Phase 4 NCT02299947 Aug 2014 → Apr 2018 hemorrhagic disease, thoracic aortic aneurysm St. Antonius Hospital Terminated No outcome recorded
Phase 4 NCT02155725 Apr 2014 → Aug 2018 LFB Completed No outcome recorded
Phase not applicable13 trials
NCT06582420 Jan → Aug 2025 overdue Unidade Local de Saude do Arco Ribeirinho Not yet recruiting No outcome recorded
NCT05490940 Mar 2023 → Dec 2025 peripheral nerve lesion Insel Gruppe AG, University Hospital Bern Unknown No outcome recorded
NCT04602689 Oct 2020 → Jul 2022 gastric adenoma, gastric carcinoma Seoul National University Hospital Completed No outcome recorded
NCT03784794 Nov 2018 → Nov 2020 acquired coagulation factor deficiency, hemorrhagic disease Angel Augusto Perez Calatayud Completed No outcome recorded
NCT03801135 Oct 2018 → Sep 2019 Guillain-Barre syndrome, Miller Fisher syndrome, anti-glomerular basement membrane disease, chronic inflammatory demyelinating polyradiculoneuropathy +2 University Medical Centre Ljubljana Unknown No outcome recorded
NCT01816282 Mar 2011 → Apr 2012 osteoarthritis, knee University of Milan Completed No outcome recorded
NCT01649505 Jan 2011 → Jan 2012 breast cancer OHSU Knight Cancer Institute Terminated No outcome recorded
NCT01226914 Jun 2010 → Jul 2014 goiter, thyroid tumor Medical University of South Carolina Completed No outcome recorded
NCT00440921 Dec 2008 → Dec 2009 osteoarthritis, knee Sanquin Research & Blood Bank Divisions Withdrawn No outcome recorded
NCT00713596 Jul 2008 → Jan 2010 Mayo Clinic Terminated No outcome recorded
Also used as a comparator or background therapy in 39 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05553132 Background Aug 2023 → Dec 2026 expected cartilage development disorder Daniel B. F. Saris Active not recruiting No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT06793748 Comparator Jun → Nov 2025 overdue chronic ulcer of skin Rion Inc. Not yet recruiting No outcome recorded
Phase 1/2 NCT02203968 Comparator Oct 2014 → Dec 2015 blood coagulation disease, hemorrhagic disease Sunnybrook Health Sciences Centre Completed No outcome recorded
Phase 1/2 NCT01475344 Comparator Sep 2011 → Oct 2015 Medical University Innsbruck Completed No outcome recorded
Phase 1/2 NCT00493272 Comparator Jun 2007 → Apr 2008 blood coagulation disease Christian Fenger-Eriksen Completed No outcome recorded
Phase 213 trials
Phase 2 NCT06319287 Comparator Feb 2024 → Apr 2025 ulcer of lower limbs Rion Inc. Completed No outcome recorded
Phase 2 NCT05780125 Comparator Mar 2023 → Feb 2024 coagulation protein disease, heart disorder, hemorrhagic disease IRCCS Policlinico S. Donato Completed No outcome recorded
Phase 2 NCT05264922 Background Jan → Jul 2022 rotator cuff syndrome AdventHealth Withdrawn No outcome recorded
Phase 2 NCT06840561 Background Nov 2021 → Dec 2024 esophageal cancer Sun Yat-sen University Cancer Center Completed No outcome recorded
Phase 2 NCT03449082 Background Mar 2018 → Jul 2019 epicondylitis Seoul National University Hospital Completed No outcome recorded
Phase 311 trials
Phase 3 NCT04612465 Comparator Jan 2020 → Apr 2025 overdue intestinal fistula Anterogen Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT03461406 Comparator Jan 2019 → Apr 2022 Grifols, S.A. Completed No outcome recorded
Phase 3 NCT04149171 Comparator Sep 2018 → Dec 2020 Cristina Martinez Completed No outcome recorded
Phase 3 NCT02553122 Comparator Oct 2015 → Oct 2016 osteoarthritis, knee Montefiore Medical Center Withdrawn No outcome recorded
Phase 3 NCT01623531 Comparator Feb 2014 → Mar 2019 cardiac valvular defect Nova Scotia Health Authority Completed No outcome recorded
Phase 49 trials
Phase 4 NCT03733639 Comparator Jul 2020 → Jul 2021 gastric cancer, intestinal perforation Germans Trias i Pujol Hospital Unknown No outcome recorded
Phase 4 NCT03884725 Comparator Mar → Jun 2019 coagulation protein disease Filomena R B G Galas Unknown No outcome recorded
Phase 4 NCT03310060 Comparator Nov 2017 → Aug 2018 Chang Gung Memorial Hospital Unknown No outcome recorded
Phase 4 NCT02822599 Comparator Jun 2017 → Aug 2019 coagulation protein disease, hemorrhagic disease Nicklaus Children's Hospital f/k/a Miami Children's Hospital Completed No outcome recorded
Phase 4 NCT03014700 Comparator Mar 2016 → Apr 2018 congenital heart disease Stanford University Completed No outcome recorded
Phase not applicable1 trial
NCT02540434 Comparator Oct 2015 → Jul 2016 blood coagulation disease Weill Medical College of Cornell University Terminated No outcome recorded

Press releases naming this drug 8 releases

DateIssuerRelease
2021-02-01 Takeda Takeda Completes Sale of TachoSil ® to Corza Health takeda.com
2020-09-16 Takeda Takeda to Divest TachoSil ® to Corza Health for €350 Million takeda.com
2016-04-27 Takeda European Commission Approves Surgical Patch TachoSil ® (human thrombin/human fibrogen) for Use in Neurological Surgery takeda.com
2014-09-16 CSL Behring CSL Behring Announces Last Patient Treated in Phase III Study of Fibrinogen Concentrate to Control Bleeding During Aortic Aneurysm Surgery csl.com
2012-12-19 CSL Behring Phase II Study Indicates that Fibrinogen Concentrate Given as a First-Line Therapy Safely Reduces Need for Transfusion after Aortic Surgery csl.com
2012-03-15 CSL Behring CSL Behring Announces First Patient Treated in Phase III Study of Fibrinogen Concentrate (Human)(FCH) to Control Bleeding During Aortic Aneurysm Surgery csl.com
2009-03-11 CSL Behring CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP csl.com
2009-01-16 CSL Behring CSL Behring Receives FDA Approval of RiaSTAP, First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency csl.com

Evidence & citations 35 cited values

Every value below carries the sentence it was read from. 127 sources stand behind the page.

FieldValueCited text
Known as Fibrinogen Concentrate (Human) “OBJECTIVES: To assess the pharmacokinetic (PK) profile, clot integrity and safety of fibrinogen concentrate (human) (FCH) in patients with afibrinogenemia.” PMID 19804533 Oct 2009
8

“RiaSTAP, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes.” NCT03304899

NCT03183479

NCT05091684

NCT00916656

NCT04434001

NCT03780894

NCT01475669

NCT03784794

Known as BIOSTAT BIOLOGX ClinicalTrials.gov intervention name — accepted as the source's own label NCT01011816
Known as BT524 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02065882
1

NCT03444324

Known as EVARREST ClinicalTrials.gov intervention name — accepted as the source's own label NCT01681030
Known as EVARREST Fibrin Sealant Patch “EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components...” NCT01681030
Known as EVICEL “This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL(™) Fibrin Sealant (Human)) during vascular surgery.” PMID 20730858 Aug 2010
8

NCT03461406

NCT01816282

NCT01226914

NCT01174992

NCT02227706

NCT02553122

NCT01235715

NCT02309645

Known as EVICEL Fibrin Sealant ClinicalTrials.gov intervention name — accepted as the source's own label NCT01589822
1

NCT02457546

Known as FCH “OBJECTIVES: To assess the pharmacokinetic (PK) profile, clot integrity and safety of fibrinogen concentrate (human) (FCH) in patients with afibrinogenemia.” PMID 19804533 Oct 2009
2

“Single-dose human fibrinogen concentrate (FCH) was associated with the transfusion of increased allogeneic blood products (ABPs) versus placebo.” PMID 30462259 Apr 2019

“Fibrinogen Concentrate, Human (FCH)” NCT00916656

Known as FGTW “Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency” NCT02094430
1

“Fibrinogen (FGTW)” NCT01955811

Known as FIB Grifols ClinicalTrials.gov intervention name — accepted as the source's own label NCT04636268
Known as Fibrin adhesive “•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesiveNCT01803347
Known as Fibrin glue “2. A topical adhesive of either 2-Octylcyanoacrylate glue (Dermabond), or Fibrin glue, or Histoacryl glue (Tissue Seal), will be applied over the fistula's aperture.” NCT03920306
11

NCT01306370

NCT01631448

NCT05553132

NCT04612465

NCT02150720

NCT06840561

NCT03449082

NCT01306851

NCT02298023

NCT01803347

NCT02153593

Known as Fibrin Sealant Fibrin Sealant (Tisseel) used in the Experimental Arm.” NCT00324272
13

NCT01649505

NCT00161915

NCT01538927

NCT07455591

NCT00028951

NCT00506311

NCT01244425

NCT04621799

NCT00161759

NCT01472913

NCT00440921

NCT01126060

NCT02343263

Known as fibrinogen “Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).” NCT01662856
15

“single dose fibrinogen concentrate immediately after CTC leads to a decrease in the number of allogenic blood transfusions” NCT02299947

NCT05300672

NCT00713596

NCT02203968

NCT02281500

NCT01539057

NCT00493272

NCT01471730

NCT04376762

NCT02344069

NCT01623531

NCT04405518

NCT05391412

NCT00968045

NCT01359878

Known as Fibrinogen concentrate ClinicalTrials.gov intervention name — accepted as the source's own label NCT02155725
18

NCT02528708

NCT01187225

NCT03508141

NCT03932240

NCT06582420

NCT01545635

NCT02542306

NCT02864875

NCT04111822

NCT03014700

NCT02745041

NCT01475344

NCT04807621

NCT00994045

NCT03801135

NCT03884725

NCT05449834

NCT04149171

Known as Fibrinogen human ClinicalTrials.gov intervention name — accepted as the source's own label NCT00365248
1

NCT00440401

Known as Fibrocaps ClinicalTrials.gov intervention name — accepted as the source's own label NCT01527357
2

NCT02284256

NCT01256190

Known as Haemocomplettan P “Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with...” NCT01187225
4

“Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump.” NCT03884725

NCT01124981

NCT01575756

NCT00701142

Known as Human Fibrinogen “Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen...” NCT00658723
4

“These samples will be spiked with Human Fibrinogen and clotting tests will be performed.” NCT01955811

“Equine collagen with Human Fibrinogen and Human Thrombin” NCT01681030

“Equine collagen with Human Fibrinogen and Human Thrombin” NCT02040428

NCT00290836

Known as Human Fibrinogen concentrate “Drug: Human Fibrinogen concentrateNCT02155725
5

“Drug: Human Fibrinogen ConcentrateNCT01475344

NCT01487837

NCT01283321

NCT04602689

NCT02094430

Known as Porcine fibrin sealant kit “The operator checked the wound to make sure there was no bleeding or perforation after the TA injection, then sprayed 5-10ml fibrin glue (Porcine fibrin sealant kit, China) on...” NCT06840561
Known as PRO-0601 “Other Names: * Raplixa * PRO-0601 * Fibrin sealant” NCT02284256
Known as Raplixa ClinicalTrials.gov intervention name — accepted as the source's own label NCT02117349
Known as Riastap “The drug used in this study is Riastap, 1g (Fibrinogen).” NCT04405518
7

“Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]” NCT03780894

NCT02540434

NCT05780125

NCT01910675

NCT03304899

NCT01300286

NCT02822599

Known as RiaSTAPTM “Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.” NCT01575756