Delving into the Latest Updates on Factor XIII(CSL Behring LLC) with Synapse

Overview

Basic Info

Drug Type

Non-recombinant coagulation factor

Synonyms

Blood coagulation factor XIII, Coagulation factor XIII, Corifact

+ [10]

Target

Fibrinogen

Action-

Mechanism

Factor XIII replacements

Therapeutic Areas

Cardiovascular DiseasesCongenital DisordersHemic and Lymphatic Diseases+ [1]

Active Indication

Postoperative HemorrhageFactor XIII DeficiencyVasculitis

Inactive Indication

HemophiliaScleroderma, Systemic

Originator Organization

CSL Behring LLC

Active Organization

CSL Behring LLCCSL Behring GmbH

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (01 Sep 1994),

Factor XIII DeficiencyVasculitis

Regulation-

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Structure/Sequence

Sequence Code 26728

The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH).
Summary of current body of evidence:
* Morbidity and mortality due to PPH is rising.
* Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy, despite non-conclusive evidence in all prospective trials.
* Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications; a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss.
Therefore, this nationwide, multi-center, randomized, controlled trial in multiple perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII.
All participating women receive, according to the national guideline, 1g tranexamic acid (TXA) i.v. in case of PPH (measured blood loss [MBL] ≥ 500 mL) during the pre-study phase. Randomization takes place if bleeding continues and exceeds 700mL. The intervention group then receives FXIII (Fibrogammin®) according to approved dosage in addition to obstetric standard of care treatment for causes of PPH; the control group receives only standard of care treatment.

Start Date09 Jul 2024

Sponsor / Collaborator

University of Zurich

[+1]

DRKS00016699

/ CompletedNot ApplicableIIT

Thrombelastographic investigation of the therapy of a dilutional coagulopathy with fibrinogen and factor XIII - WarmUp

Start Date04 Feb 2019

Sponsor / Collaborator-

NCT02551042

/ Unknown statusPhase 2IIT

A Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic Sclerosis

Many patients with Scleroderma (Systemic sclerosis) experience damage to blood vessels, mainly to the small arteries. A common manifestation of this is Raynaud's phenomenon (fingers or toes turning white then blue in the cold) and digital ulcers (open sores on the fingertips). The purpose of this study is to see how effective the study drug Human Factor XIII Concentrate is in treating patients who have these and other common manifestation of Scleroderma. It will be given in addition to the accepted treatments used for this disease.

Start Date01 Sep 2015

Sponsor / Collaborator

University College London

[+1]

100 Clinical Results associated with Factor XIII(CSL Behring LLC)

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100 Translational Medicine associated with Factor XIII(CSL Behring LLC)

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100 Patents (Medical) associated with Factor XIII(CSL Behring LLC)

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149

Literatures (Medical) associated with Factor XIII(CSL Behring LLC)

29 Dec 2023·Modern rheumatology case reports

A case of anti-NPX-2 antibody-positive dermatomyositis resulting in massive haemothorax with acquired factor XIII deficiency

Article

Author: Kan, Toshiaki ; Matsuda, Takuya ; Sakaguchi, Takaaki ; Otsuka, Yasunori ; Haga, Taiki

ABSTRACT:

Autoimmune diseases, including dermatomyositis, can be complicated by an acquired autoimmune coagulation factor XIII deficiency, which sometimes results in fatal bleeding. Here, we report the case of a young woman with anti-NPX-2 antibody-positive dermatomyositis who developed massive haemothorax with acquired factor XIII deficiency during treatment, including plasma exchange therapy. Emergency transcatheter arterial embolisation was performed and coagulation factor XIII concentrates (Fibrogammin P® 240 U/day for 5 days) were supplemented. Subsequently, the patient was discharged and managed with oral prednisolone and tacrolimus. Coagulation system test results were followed up regularly and remained within normal limits and the patient progressed without recurrence of bleeding symptoms. Coagulation factor XIII deficiency cannot be assessed without measuring coagulation factor XIII activity because common coagulation-fibrinolytic system test results are not abnormal. The measurement of factor XIII activity should be performed when autoimmune diseases are complicated by unexplained bleeding.

01 Aug 2023·The clinical respiratory journal

A retrospective comparison between digital to conventional drainage systems for secondary spontaneous pneumothorax related to diffuse interstitial lung disease.

Review

Author: Hirama, Ryutaro ; Kawasaki, Takeshi ; Nakamura, Hidenori ; Horiuchi, Dai ; Shikano, Kohei ; Ishii, Daisuke ; Maruyama, Kanae ; Suzuki, Takuji ; Sakuma, Noriko ; Kitahara, Shinsuke ; Abe, Mitsuhiro

INTRODUCTION:

Secondary spontaneous pneumothorax (SSP) occurs as one of the complications associated with interstitial pneumonia (IP). Chest drainage is performed when there is a large volume of air in the pleural space. Notably, SSP with IP (SSP-IP) is frequently not curable by chest drainage only. A digital drainage system (DDS) provides an objective evaluation of air leakage and maintains a pre-determined negative pressure, compared to an analog drainage system (ADS). Few studies have reported the effectiveness of DDS in the treatment of SSP-IP. This study aimed to assess the usefulness of DDS for SSP-IP.

METHODS:

This retrospective study included patients with SSP-IP who had undergone chest drainage. We reviewed the included patients' medical records, laboratory data, computed tomography findings, and pulmonary function data.

RESULTS:

DDS was used in 24 patients and ADS in 49 patients. The mean duration of chest drainage was 11.4 ± 1.9 days in the DDS group and 14.2 ± 1.3 days in the ADS group, which was not significantly different (p = 0.218). Surgery, pleurodesis, and/or factor XIII administration were performed in 40 patients. Additionally, five (20.8%) patients in the DDS group and nine (18.4%) in the ADS group had a recurrence of pneumothorax within 4 weeks (p = 1.000). One patient (14%) in the DDS group and six (12.2%) in the ADS group (p = 0.414) were cured of pneumothorax but later died.

CONCLUSION:

DDS did not demonstrate a significant difference in the shortening of chest drainage duration. Further study is needed to validate the results of this study.

01 Jul 2023·Blood transfusion = Trasfusione del sangue

Achieving haemostasis in thrombocytopenia in remote settings: an in vitro comparison of frozen and lyophilized products.

Article

Author: Crispin, Philip J ; Gardiner, Elizabeth E ; Coupland, Lucy A

BACKGROUND:

Platelet concentrates have a limited shelf life due to room temperature storage and therefore, are not kept in regional centres where turnover is low. Cryopreserved platelets have been proposed as an alternative to platelet transfusion in austere circumstances and fibrinogen concentrate has improved thromboelastometry parameters in thrombocytopenia. This study compared the ability of stored haemostatic products and platelets to correct thromboelastometry parameters in thrombocytopenia.

MATERIALS AND METHODS:

Blood from eight patients with severe thrombocytopenia was combined with platelet concentrates, cryoprecipitate, fibrinogen concentrate, factor VIII, factor XIII and cryopreserved platelets in ratios equivalent to transfusion. Tissue factor initiated thromboelastometry (EXTEM) was compared between the products.

RESULTS:

EXTEM amplitude at 20 minutes (A20) improved by 13.1 mm with platelets (p<0.01). The 5mm increase in A20 seen with cryoprecipitate (p=0.06) was not statistically different from platelets (p=0.19). No improvement in A20 was observed with cryopreserved platelets or factor concentrates. EXTEM clotting times (CT) improved with cryopreserved platelets (19.4 s, p=0.001) and cryoprecipitate (24.1 s, p<0.05), but not fibrinogen, and both were superior to platelets (9.9 s, p<0.05). Clotting concentrates did not improve EXTEM parameters although further studies suggested the improvement in A20 was largely driven by higher fibrinogen concentrations in cryoprecipitate.

DISCUSSION:

These results suggest that cryopreserved platelets enhance clot initiation but do not contribute to clot strength in thrombocytopenia. When platelets are not available for transfusion, cryoprecipitate may be of value, however this requires further clinical studies.

100 Deals associated with Factor XIII(CSL Behring LLC)

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External Link

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-	Factor XIII(CSL Behring LLC)	B02BD07	DB12909

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Postoperative Hemorrhage	United States	CSL Behring GmbH	17 Feb 2011
Factor XIII Deficiency	Japan	CSL Behring LLC	01 Sep 1994
Vasculitis	Japan	CSL Behring LLC	01 Sep 1994

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Scleroderma, Systemic	Phase 2	United Kingdom	CSL Behring LLC	01 Sep 2015
Hemophilia	Clinical	United States	CSL Behring LLC	01 Jan 2000

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2014	Not Applicable	Acute Lymphoblastic Leukemia	-	Coagulation Factor XIII (FXIIIA-positive ALL)	qeryibcfzj(ckmpgutsvd) = wfwpksgqcf imxtrayunz (egafcvxvhp )	-	06 Dec 2014
ASH2014	Not Applicable	Acute Lymphoblastic Leukemia	-	Coagulation Factor XIII (FXIIIA-negative ALL)	qeryibcfzj(ckmpgutsvd) = dpbnwxbrfo imxtrayunz (egafcvxvhp )	-	06 Dec 2014
NCT00883090 (CTgov)	Phase 2	Factor XIII Deficiency	15	FXIII Concentrate (Human)	mlgwswtdkc(rvwhpztqvq) = qgemrykyhp gjhfmbaxfw (gtlnueeegy, 0.20) View more	-	16 Jan 2012

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Biosimilar

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