Human fibrinogen concentrate(LFB Biomedicaments)(Human fibrinogen concentrate(LFB Biomedicaments)) - 在研适应症：纤维蛋白原缺乏血症_专利_临床

概要

基本信息

药物类型

重组凝血因子

别名

Clottafact、FGTW、Fibrinogen(LFB Biomedicaments)

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靶点-

作用机制

Fibrinogen replacements(纤维蛋白原替代物)

治疗领域

遗传病与畸形血液及淋巴系统疾病其他疾病

在研适应症

纤维蛋白原缺乏血症

非在研适应症-

原研机构

LFB Biomedicaments SA

在研机构

LFB Biomedicaments SA

非在研机构-

最高研发阶段批准上市

首次获批日期

德国 (2016-02-15),

纤维蛋白原缺乏血症

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Human fibrinogen concentrate(LFB Biomedicaments) 相关的临床试验

EUCTR2013-000261-36-Outside-EU/EEA / Unknown statusN/A

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

开始日期-

申办/合作机构

LFB Biotechnologies SASU

NCT05780125 / Completed临床2期IIT

Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

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).

开始日期2023-03-20

申办/合作机构-

NCT02155725 / Completed临床4期

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.

开始日期2014-04-10

申办/合作机构

Laboratoire Français du Fractionnement et des Biotechnologies

100 项与 Human fibrinogen concentrate(LFB Biomedicaments) 相关的临床结果

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100 项与 Human fibrinogen concentrate(LFB Biomedicaments) 相关的转化医学

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100 项与 Human fibrinogen concentrate(LFB Biomedicaments) 相关的专利（医药）

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30

项与 Human fibrinogen concentrate(LFB Biomedicaments) 相关的文献（医药）

2023-11-01·Journal of clinical pharmacology

Real-World Experience with a Human Fibrinogen Concentrate: Clinical Data from Adult and Pediatric Patients Requiring Fibrinogen for Bleeding Control and Prevention.

Article

作者: Djabarouti, Sarah ; Fardini, Yann ; Hébert, Guillaume ; Clerson, Pierre ; Stéphan, Francois ; Bourget, Stéphanie ; Gutermann, Loriane ; Berdugo, Johanna ; Belmokhtar, Chafké

Human fibrinogen concentrate (Fibryga) received temporary approval for fibrinogen replacement therapy in France (2017), with subsequent full approval for congenital and acquired hypofibrinogenemia. We evaluated real-world use for on-demand treatment of bleeding and prophylaxis to enhance our knowledge on fibrinogen concentrate as an option for fibrinogen replacement. Data were retrospectively collected from adult and pediatric patients with fibrinogen deficiency. The primary end point was indication for fibrinogen concentrate use; the secondary end point was treatment success for on-demand treatment/perioperative prophylaxis. The study included 150 adult (median age, 62 years; range, 18-94 years) and 50 pediatric (median age, 3 years; range, 0.01-17 years) patients with acquired fibrinogen deficiency. Fibrinogen concentrate was administered to 47.3% for nonsurgical bleeding, 22.7% for surgical bleeding, and 30.0% for perioperative prophylaxis in adult patients, and to 4.0% for surgical bleeding and 96.0% for perioperative prophylaxis in pediatric patients. Cardiac surgeries accounted for 79.5%/75.0% perioperative prophylaxis and 82.4%/100.0% surgical bleeding cases in adult/pediatric patients, respectively. The mean ± standard deviation (SD, median) total fibrinogen doses were 3.06 ± 1.69 g (32.61 mg/kg), 2.09 ± 1.36 g (22.99 mg/kg), and 2.36 ± 1.25 g (29.67 mg/kg) for adult nonsurgical bleeding, surgical bleeding, and perioperative prophylaxis, respectively; doses of 0.75 ± 0.35 g (47.64 mg/kg) and 0.83 ± 0.62 g (55.56 mg/kg) were used for pediatric surgical bleeding and perioperative prophylaxis, respectively. Treatment success was 85.7%/97.1/93.3% in adults and 50.0%/87.5% in pediatrics for nonsurgical bleeding (adults only), surgical bleeding, and perioperative prophylaxis, respectively. Fibrinogen concentrate demonstrated favorable effectiveness and safety across the age groups. This study contributes to evidence supporting fibrinogen concentrate for bleeding control/prevention in real-world clinical practice, particularly for patients with acquired fibrinogen deficiency.

2022-10-01·Pediatric Cardiology4区 · 医学

A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and Blood Loss in Infants Undergoing Cardiopulmonary Bypass

4区 · 医学

Article

作者: Tirotta, Christopher F ; Hannan, Robert ; Kubes, Kathleen ; Gupta, Apeksha ; Burke, Redmond P ; Lagueruela, Richard G ; Salyakina, Daria ; Ojito, Jorge ; Aguero, David

AbstractThe objective of this study was to determine whether treatment with human fibrinogen concentrate decreases the need for component blood therapy and blood loss in neonate and infant patients undergoing cardiopulmonary bypass. Pediatric patients (N = 30) undergoing elective cardiac surgery were randomized to receive human fibrinogen concentrate or placebo following cardiopulmonary bypass termination. The primary endpoint was the amount of cryoprecipitate administered. Secondary endpoints included estimated blood loss during the 24 h post-surgery; perioperative blood product transfusion; effects of fibrinogen infusion on global hemostasis, measured by laboratory testing and rotational thromboelastometry; and adverse events. No clinically significant differences were identified in baseline characteristics between groups. A significantly lower volume of cryoprecipitate was administered to the treatment group during the perioperative period [median (interquartile range) 0.0 (0.0–0.0) cc/kg vs 12.0 (8.2–14.3) cc/kg; P < 0.0001] versus placebo. No difference was observed between treatment groups in blood loss, laboratory coagulation tests, use of other blood components, or incidence of adverse events. FIBTEM amplitude of maximum clot firmness values was significantly higher among patients treated with human fibrinogen concentrate versus placebo (P ≤ 0.0001). No significant differences were observed in post-drug HEPTEM, INTEM, and EXTEM results. Human fibrinogen concentrate (70 mg/kg) administered after the termination of cardiopulmonary bypass reduced the need for transfusion with cryoprecipitate in a neonate and infant patient population.ClinicalTrials.gov identifier: NCT02822599.

2021-11-01·Acta Anaesthesiologica Scandinavica4区 · 医学

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

4区 · 医学

Article

作者: 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.

100 项与 Human fibrinogen concentrate(LFB Biomedicaments) 相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
纤维蛋白原缺乏血症	德国	LFB Biomedicaments SA	2016-02-15

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临床结果

适应症

分期

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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


ISTH2022	N/A	纤维蛋白原缺乏血症	30	Fibclot	膚淵願鏇鑰觸選獵齋餘(積衊積積網繭壓觸醖範) = 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. 鏇鹽壓範醖網製遞憲衊 (獵餘蓋範網鹹齋顧願廠 )	-	2022-07-09