30 closest matches · ranked by relevance
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…
Factor XIII Deficiency
Primary: Adverse Events — 42; 2; 2 participants
Hemophilia · Factor XIII Deficiency
Primary: Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions — 30; 1; 0; 3 Number of bleeds
Factor XIII Deficiency
Primary: Peak FXIII Concentration at Steady State — 0.9 Units/mL
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Area Under the Concentration vs. Time Curve (AUC) — 250.25 IU*h/mL
Severe Hemophilia A
Primary: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors — 17; 11; 28 Participants
Hemophilia A With Inhibitors · Hemophilia B With Inhibitors
Primary: Proportion of Successfully Treated Mild/Moderate Bleeding Episodes — .849; .932 Proportion of Success of BEs
Congenital Afibrinogenemia · Congenital Hypofibrinogenemia
Primary: Single-dose Pharmacokinetics (PK) of BT524: Terminal Elimination Half-life (t1/2) for Fibrinogen Antigen — 67.9 hours
Hemophilia A
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 2; 5 Participants
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Adverse Events (AEs)(Serious and Non-serious) — 920; 19; 901 Events
Hemophilia A · Severe Hemophilia A
Primary: Incidence of Inhibitor Formation to FVIII in Previously Treated Patients (PTPs) With 100 Exposure Days (EDs) to CSL627 — 0 percentage of paticipants
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…
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Number of Treatment Emergent (Serious and Non-serious) Adverse Events — 100; 2; 98 number of events
Congenital Hemophilia A
Primary: Treatment Success — 96.3 Percentage of treated bleeding events
Hemophilia A
Primary: Number of Participants With FVIII Inhibitor Development — 11 Participants
Hemophilia A
Primary: Annualized Number of Total Bleeds in On-demand Treatment Arm (Weeks 0 -36) and in Each Prophylaxis Arm (Weeks 10 - 36, Excluding Rescue Bleeds) - Part A, Main Trial…
Hemophilia A
Primary: Percentage of Participants With Confirmed Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay — 31.11 percentage of participants
Hemophilia A
Primary: The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS — 0.39; 0.38 h IU/mL (IU/kg)
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…
Hemophilia A
Primary: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) — 122.0; 130.2; 120.2; 124.2 mmHg
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
Fibrinogen Deficiency
Primary: Maximum Clot Firmness (MCF) — 0; 8.9 millimeters — p=<0.0001
Hemophilia A With Inhibitors · Hemophilia B With Inhibitors
Primary: Proportion of Successfully Treated Mild/Moderate Bleeding Episodes Per FDA Requirement. — 0.654; 0.603 Proportion of successfully treated BEs
Hemophilia B
Primary: Number of Subjects Who Achieved FIX Level ≥12% — 3; 4; 4; 4 Participants
Hemophilia A · Hemophilia B · Hemophilia A With Inhibitor
Primary: Comparative MarzAA Activity by Dose Level/Stage - AUC0-∞ and AUC0-last — 1390.0; 516.4; 849.4; 1060.0 h*ng/mL
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
Hemophilia A
Primary: Initial Recovery — 1.7; 1.6; 1.8 IU/dL per IU/kg — p=0.1662
Hemophilia B
Primary: Factor IX Activity Levels — 30.6 Factor IX activity (%)
Acquired Hemophilia A
Primary: Percentage of Serious Bleeding Episodes Responsive to OBI-1 — 100 percentage of serious bleeding episodes — p=<0.001
Hemophilia A
Primary: Percentage of Participants Who Developed Factor VIII (FVIII) Inhibitors — 0 percentage of participants