Delving into the Latest Updates on Human fibrinogen concentrate(LFB Biomedicaments) with Synapse

Overview

Basic Info

Drug Type

Recombinant coagulation factor

Synonyms

Clottafact, FGTW, Fibrinogen(LFB Biomedicaments)

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Target-

Action-

Mechanism

Fibrinogen replacements(Fibrinogen replacements)

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Afibrinogenemia

Inactive Indication-

Originator Organization

LFB Biomedicaments SA

Active Organization

LFB Biomedicaments SA

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Germany (15 Feb 2016),

Afibrinogenemia

Regulation-

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Fibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RiaSTAP (CSL Behring), FIBRYGA (Octapharma), and FibCLOT (LFB). RiaSTAP and FIBRYGA are sold in 1-gram vials, and FibCLOT - in 1.5-gram vials. A recent in vitro study assessed how these products affected the clot firmness measured by the ROTEM FIBTEM maximum clot firmness (MCF) parameter. In vitro conditions, FibCLOT was verified to be the most efficient in increasing clot firmness.
The present study is aimed to assess, in a series of patients undergoing cardiac surgery with cardiopulmonary bypass, the hypothesis that the FibCLOT fibrinogen is superior to the RiaSTAP fibrinogen in increasing the FIBTEM MCF parameter in a clinical model of bleeding (postoperative bleeding after complex cardiac surgery).

Start Date20 Mar 2023

Sponsor / Collaborator-

NCT02155725

/ CompletedPhase 4

Study on the Efficacy and Safety of a Therapeutic Strategy of PPH Comparing Early Administration of Human Fibrinogen vs Placebo in Patients Treated With IV Prostaglandins Following Vaginal Delivery

The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.

Start Date10 Apr 2014

Sponsor / Collaborator

Laboratoire Français du Fractionnement et des Biotechnologies

EUCTR2013-000261-36-FR

/ Not yet recruitingPhase 2/3

Clinical pharmacology, efficacy and safety study of FGTW in paediatric patients with severe congenital fibrinogen deficiency

Start Date29 Nov 2013

Sponsor / Collaborator

LFB Biotechnologies SASU

100 Clinical Results associated with Human fibrinogen concentrate(LFB Biomedicaments)

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100 Translational Medicine associated with Human fibrinogen concentrate(LFB Biomedicaments)

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100 Patents (Medical) associated with Human fibrinogen concentrate(LFB Biomedicaments)

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9

Literatures (Medical) associated with Human fibrinogen concentrate(LFB Biomedicaments)

01 Apr 2025·Anesthesia & Analgesia

A Randomized Controlled Trial Comparing Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

Article

Author: Di Dedda, Umberto ; Caravella, Giuseppe ; Baryshnikova, Ekaterina ; Ranucci, Marco ; Anguissola, Martina ; Aloisio, Tommaso ; Barbaria, Alessandro

BACKGROUND:Different preparations of fibrinogen concentrate are currently available. Two in vitro studies demonstrated the superiority of FibCLOT (LFB) in increasing clot firmness with respect to RiaSTAP (CSL Behring). The present trial involved a clinical model to test the hypothesis of superiority, with the increase in clot firmness as the primary end point.METHODS:Forty cardiac surgery patients were randomly allocated to receive a dose of 30 mg/kg FibCLOT or RiaSTAP after protamine administration in the presence of microvascular bleeding and a FIBTEM maximum clot firmness (MCF) <10 mm. Viscoelastic parameters were measured before and after fibrinogen supplementation: FIBTEM MCF, EXTEM MCF, and EXTEM clotting time (CT).RESULTS:The mean increase in FIBTEM MCF was 4 ± 1.2 mm (mean and standard deviation) in the FibCLOT group and 4 ± 1.6 mm in the RiaSTAP group (P = 1.000); the mean decrease in CT was 11. 2 ± 12.2 (mean and standard deviation) seconds in the FibCLOT group and 14. 8 ± 13 seconds in the RiaSTAP group (P = .372). In both groups, fibrinogen supplementation induced a significant (P = .001) increase in the FIBTEM MCF and EXTEM CT. The proportions of patients who did not experience an increase of 4 mm in the RiaSTAP group and the FibCLOT group were not statistically significantly higher (35% vs 20%, respectively, relative risk 2.15, 95% confidence interval 0.52–9.00, P = .288).CONCLUSIONS:In contrast to previous in vitro studies, we found that the effect of FibCLOT on MCF and CT was not significantly greater than that of RiaSTAP in cardiac surgery patients. Further studies in other clinical settings are warranted.

01 Nov 2021·Acta Anaesthesiologica ScandinavicaQ4 · MEDICINE

A comparison of the in vitro effects of three fibrinogen concentrates on clot strength in blood samples from cardiac surgery patients

Q4 · MEDICINE

Article

Author: Shams Hakimi, Caroline ; Stolt, Henrik ; Jeppsson, Anders ; Karlsson, Martin ; Singh, Sukhi

AbstractBackgroundFibrinogen concentrate is used clinically to improve hemostasis in bleeding patients. We investigated and compared the efficacy of three commercially available fibrinogen concentrates to improve clot strength in blood samples from cardiac surgery patients.ObjectivesPostoperative blood samples were collected from 23 cardiac surgery patients. Samples were each divided into four vials, each supplemented with 1.125 mg of fibrinogen of one of three fibrinogen concentrates (RiaSTAP®, Fibryga®, FibCLOT®), or placebo. The fibrinogen dose corresponded to 2.5 g per 70 kg of body weight. Clot strength after supplementation was assessed in duplicate with rotational thromboelastometry (ROTEM®) using FIBTEM maximum clot firmness, EXTEM clot formation time, and maximum clot firmness assays.ResultsIn vitro fibrinogen concentrate supplementation of the samples resulted in higher plasma fibrinogen concentrations and improved clot strength with all three concentrates. Supplementation with FibCLOT increased FIBTEM maximum clot firmness (+46% [25th–75th percentile 35–55] compared to placebo) significantly more than did supplementation with Fibryga (+26% [21–35]) and RiaSTAP (+29% [22–47], p < .001). FibCLOT supplementation also shortened EXTEM clot formation time and increased EXTEM maximum clot firmness to a greater extent than did the other concentrates (both p < .001).ConclusionsAt the selected dose, FibCLOT was more effective than Fibryga and RiaSTAP in restoring clot strength in postoperative blood samples from cardiac surgery patients. These results may have implications for the choice of fibrinogen concentrate and dosing.

01 May 2020·Clinical Drug Investigation

Observational Safety Study of Clottafact® Fibrinogen Concentrate: Real-World Data in Mexico

Article

Author: Rodríguez-Ayala, Ernesto ; Pérez-Calatayud, Ángel Augusto ; Hernández-Salgado, Lidia ; Posadas-Nava, Alejandro ; Padilla-Molina, Misael ; Olvera-Vázquez, Susana ; Colin-Bracamontes, Ignacio ; Carrillo-Esper, Raúl

BACKGROUND AND OBJECTIVEThe use of fibrinogen concentrate to treat or prevent major bleeding with regard to potential adverse reactions has not been free of controversy. Our objective was to perform a post-authorization safety study to describe the use of Clottafact^® (LFB Biomedicaments) fibrinogen concentrate in real-life medical practice in Mexico.METHODSThis was a prospective, observational study that collected and evaluated information between January 2017 and June 2019 related to suspected serious adverse reactions (SUSARs) during and after Clottafact^® infusion.RESULTSInformation from 40 subjects was analyzed; 43% were women (n = 17), mean age was 39.05 ± 26.8 years (range 0-91 years). The medical specialties included in this analysis were cardiac surgery - 52.5% of the cases, gynecology/obstetrics - 17.5%, general surgery and orthopedics - 12.5% each, and hematology and neurosurgery - 2.5%, respectively. Mean plasma fibrinogen levels before and after Clottafact^® infusion were 2.58 g/L and 4.02 g/L; p = 0.001, respectively. The mean Clottafact^® dose was 2.20 ± 0.77 g. One patient presented SUSARs (dry mouth and dysgeusia) with drug administration, which ceased after treatment discontinuation.CONCLUSIONSIn this real-life post-marketing study, the safety profile of Clottafact^® was very similar to previous reports. Thus, Clottafact^® shows a favorable safety profile in clinical practice.

100 Deals associated with Human fibrinogen concentrate(LFB Biomedicaments)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Afibrinogenemia	Germany	LFB Biomedicaments SA	15 Feb 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2022	Not Applicable	Afibrinogenemia	30	Fibclot	fleylvndcw(fvzhucqyqs) = One patient with DIC experienced expressive dysphasia during the infusion of Fibclot. The infusion was stopped and a subsequent CT head was normal. Her symptoms resolved within 24hours and she received further doses of Fibclot without neurological symptoms. zyleuwtege (fhotvpgzet )	-	09 Jul 2022

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