Phase 2 N=15 Human Fibrinogen - Pharmacokinetics
Fibrinogen Deficiency
Primary: Maximum Clot Firmness (MCF) — 0; 8.9 millimeters — p=<0.0001
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Phase 3 N=35 Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency
Congenital Afibrinogenemia · Congenital Hypofibrinogenemia
Primary: Single-dose Pharmacokinetics (PK) of BT524: Terminal Elimination Half-life (t1/2) for Fibrinogen Antigen — 67.9 hours
N/A N=72 Clinical Trial of Factor XIII (FXIII) Concentrate
Hemophilia · Factor XIII Deficiency
Primary: Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions — 30; 1; 0; 3 Number of bleeds
Phase 4 N=60 Fibrinogen Concentrate vs Cryoprecipitate
Congenital Heart Disease
Primary: Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival. — 5; 4 ADT units
Phase 2 N=22 Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia
Congenital Afibrinogenemia
Primary: Area Under the Plasma Fibrinogen Concentration-time Curve (AUC) From Time Zero to 14 Days (AUC0-14days) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70…
Phase 4 N=437 Fibrinogen in Haemorrhage of Delivery
Post-Partum Hemorrhage
Primary: Failure Rate of PPH Management — 75; 80; 92; 92 Participants — p=0.9563
Phase 4 N=30 Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
Hypofibrinogenemia · Afibrinogenemia · Bleeding Disorders
Primary: Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) — 35; 33 cc/kg
Phase 3 N=36 In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
Hemostasis
Primary: Clot Degradation at 24 Hours Post-operatively — 0.65; 0.88; 0.78; 0.46 microns per hour
Phase 3 N=61 An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Factor XIII Deficiency
Primary: Adverse Events — 42; 2; 2 participants
Phase 3 N=41 A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Factor XIII Deficiency
Primary: The Incidence of Spontaneous Bleeding Events Requiring Treatment (Treatment is Defined as Administration of a FXIII-Containing Product to Treat the Bleeding Event) — 0…
Phase 3 N=25 Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
Congenital Fibrinogen Deficiency
Primary: Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. — 19; 23; 5; 1 Participants
Phase 4 N=31 Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
Pediatric HD · Bleeding
Primary: A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48…
Phase 2 N=15 A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency
Factor XIII Deficiency
Primary: Peak FXIII Concentration at Steady State — 0.9 Units/mL
N/A N=51 Thromboelastography-derived Functional Fibrinogen Levels
Focus of Study · Coagulation Status of Cardiac Surgery Patient · Reducing Excess Blood Transfusion
Primary: Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) — -1.1 mg/dL
Phase 3 N=222 Adjusted Fibrinogen Replacement Strategy
Bleeding Disorder · Hypofibrinogenemia; Acquired
Primary: Intra-operative Blood Loss — 1380.7; 1660.13 mL — p=<0.001
Phase 3 N=6 Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Area Under the Concentration vs. Time Curve (AUC) — 250.25 IU*h/mL
Phase 2 N=22 Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
Congenital Fibrinogen Deficiency · Afibrinogenemia
Primary: Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized — 1.196 ratio
Phase 3 N=62 Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery
Cardiac Complication During Procedure
Primary: Cumulative Transfusion Units — 0; 0 Transfusion Units — p=.908
Phase 3 N=15 Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency
Congenital Fibrinogen Deficiency
Primary: Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a…
Phase 4 N=20 Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
Hypofibrinogenemia · Bleeding
Primary: Total Number of RBCs Used Over Admission — 5.8; 6.7 RBC Units
Phase 3 N=41 Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period — 0.138 bleeding episodes per subject…
Phase 3 N=18 Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Antithrombin III Deficiency
Primary: Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT) — 0 Participants
Phase 3 N=6 Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Number of Treatment Emergent (Serious and Non-serious) Adverse Events — 100; 2; 98 number of events
N/A N=452 Low Plasma Mannose Binding Lectin (p-MBL) Level is a Risk Factor for Recurrent Pregnancy Loss (RPL)
Recurrent Miscarriage · Spontaneous Abortion · Mannose-Binding Lectin Deficiency
Primary: Plasma MBL Level (ug/ml) — 717; 1717 ug/l — p=<0.001
Phase 3 N=63 Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Adverse Events (AEs)(Serious and Non-serious) — 920; 19; 901 Events
Phase 2 N=40 Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery
ATIII Deficiency
Primary: Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in…
Phase 4 N=251 Survey of Inhibitors in Plasma-Product Exposed Toddlers
Hemophilia A
Primary: To Assess the Immunogenicity of Plasma Derived VWF/FVIII and rFVIII Concentrates by Determining the Frequency of Inhibitor Development in the First 50 EDs or in the…
Phase 3 N=9 A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
Hypoplasminogenemia · Congenital Plasminogen Deficiency
Primary: Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected…
Phase 3 N=27 Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors
Hemophilia A With Inhibitors · Hemophilia B With Inhibitors
Primary: Proportion of Successfully Treated Mild/Moderate Bleeding Episodes — .849; .932 Proportion of Success of BEs
Phase 2 N=5 A Study of TAK-662 for Japanese Patients With Congenital Protein C Deficiency
Congenital Protein C Deficiency
Primary: PK Part: Protein C Activity Level of TAK-662 — 0.000; 1.746; 1.616; 1.458 international unit per milliliter(IU/ml)