Coagadex (coagulation factor X (human)) / Bio Products Lab, Kedrion - LARVOL DELTA

A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis (clinicaltrials.gov) - P3 | N=15 | Not yet recruiting | Sponsor: Kedrion S.p.A.

New P3 trial • Amyloidosis

Factor X Concentrate Treatment Schedule and Dosing in Acquired FX Deficiency. (PubMed, Hematol Rep) - "This case report adds valuable insight into the management of this rare condition, and how best to utilize FX concentrates in acquired FX deficiency."

Journal • Amyloidosis • Gastroenterology • Gastrointestinal Disorder

Preclinical development and characterization of a human plasma-derived high-purity factor X concentrate for therapeutic use. (PubMed, Haemophilia) - "Targeted pre-clinical development of the first highly-purified concentrate to treat hereditary factor X deficiency is described. Following international guidelines for nonclinical safety testing, particular strategies were adopted for unmodified products derived from human blood plasma. This approach may also be relevant to the development of other ultra-orphan medicinal products."

Journal • Preclinical • Hematological Disorders

Plasma Derived Factor X Concentrate Has Not Induced Inhibitor Development in the Clinical Setting (ASH 2022) - "Plasma derived factor X (pdFX) concentrate (Coagadex®, coagulation factor X, human, Bio Products Laboratory Ltd., Elstree, UK), has been granted a marketing license in both the US (2015) and EU (2016) for use in patients with HFXD... To date, after over six years use in the postmarketing setting, there have been no reports of inhibitor development with pdFX."

Clinical • Hematological Disorders

Prophylaxis with human coagulation factor X in an adolescent girl with hereditary major Stuart factor deficiency. (ISTH 2022) - "Later, her first menstrual period leads to anemia, requiring tranexamic acid and iron supplementation.At 16, we suggested switching to COAGADEX prophylaxis (plasma-derived blood coagulation factor X concentrate) 25 IU/kg once a week. She presented with rectal bleeding at 15 days of age, which prompted a coagulation assay showing a prothrombin index < 5%, APTT 102 s, factor X < 1%, and factor VII 20%. Factor V and VII normalized with age. Parents were first-degree relatives of Algerian origin, both had respectively factor X 46% and 59%, and the father also had heterozygous factor VII deficiency (55%)."

Anemia • Hematological Disorders • Osteoarthritis

SAFE AND EFFECTIVE PROPHYLAXIS WITH PLASMA-DERIVED FACTOR X CONCENTRATE IN AN ELDERLY PATIENT WITH HEREDITARY FACTOR X DEFICIENCY (EHA 2022) - "Additional details of this case including laboratory data and updates from her recent clinic visit(s) will be presented. The data supports the successful prophylactic treatment of elderly patients and the need to continue to collect data in this population of patients with this rare bleeding disorder."

Clinical • CNS Disorders • Hematological Disorders

Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery (clinicaltrials.gov) - P=N/A; N=3; Completed; Sponsor: Bio Products Laboratory; Recruiting ➔ Completed

Clinical • Trial completion

[VIRTUAL] Safe and Effective Prophylaxis with Plasma-derived Factor X Concentrate in an Elderly Patient with Hereditary Factor X Deficiency (ISTH 2021) - "Additional details of this case including laboratory data will be presented. The data supports the successful prophylactic treatment of elderly patients and the need to continue to collect data in this population of patients with this rare bleeding disorder."

Clinical • CNS Disorders • Hematological Disorders

Plasma-derived factor X concentrate compassionate use for hereditary factor X deficiency: Long-term safety and efficacy in a retrospective data-collection study. (PubMed, Res Pract Thromb Haemost) - "Coagadex is a high-purity plasma-derived factor X concentrate (pdFX) developed to treat hereditary factor X deficiency (FXD)...This analysis supports the use of pdFX as a safe, effective treatment for hereditary FXD. Routine prophylaxis with pdFX may reduce bleed frequency."

Journal • Retrospective data • Hematological Disorders

[VIRTUAL] HIGH-PURITY PLASMA-DERIVED FACTOR X IS EFFECTIVE FOR SHORT-TERM PREVENTATIVE USE AND PERI-SURGICAL HEMOSTATIC COVER: RESULTS FROM A RETROSPECTIVE, OPEN-LABEL, COMPASSIONATE-USE STUDY OF PATIENTS WITH HEREDITARY FACTOR X DEFICIENCY (THSNA 2020) - No abstract available

Retrospective data

Prophylaxis with prothrombin complex concentrates in FX deficiency (EAHAD 2020) - "Any plasma-derived or recombinant product containing only FX which can be used in FX deficiency is not available in our country. However, pure FX (Coagadex®) can be found abroad. Another treatment option is FX-containing prothrombin complex concentrates."

F2

Plasma-derived factor X therapy for treatment of intracranial bleeding in a patient with factor X deficiency: a case report (GTH 2019) - "...Laboratory assays showed severe coagulopathy of unknown cause; the patient was empirically treated using a multimodal hemostatic approach with prothrombin complex concentrate, fresh-frozen plasma, and tranexamic acid... Single-factor therapy with pdFX was effective and well tolerated in treating an infant with severe hereditary FXD who presented with ICH without potential thromboembolic complications.Funding: Bio Products Laboratory"

Clinical