35 trials (keyword fallback)
Hemophilia A With Inhibitor
Primary: Reduction in the Burden of the Condition Including Treatment Burden, Bleed Frequency, Pain, Control, Freedom and Missed Opportunities) — 19; 10; 12; 9 participants
Congenital Bleeding Disorder · Haemophilia A
Primary: Number of Adverse Events Reported — 58; 444; 8 Events
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…
Congenital Bleeding Disorder · Haemophilia A
Primary: The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months — 0.006; 0 Inhibitor rate
Hemophilia B
Primary: Mean Difference of Area Under the Curve (AUC): BeneFIX Compared to AlphaNine — 10.41 IU x hour/dL — p=0.77
Congenital Bleeding Disorder · Haemophilia B
Primary: Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days) — 2; 0 Participants
Congenital Bleeding Disorder · Haemophilia B
Primary: Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) — 0; 0 Number of subjects
Haemostasis · Haemophilia A
Primary: The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset — 43; 13; 14 Episodes
Congenital Bleeding Disorder · Haemophilia A
Primary: The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) — 0 N with Inhibitors / N with ≥50 EDs
Congenital Bleeding Disorder · Haemophilia A With Inhibitors · Haemophilia B With Inhibitors
Primary: The Number of Bleeding Episodes — 47; 77 episodes
Congenital Bleeding Disorder · Haemophilia A
Primary: Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) — 0; 0; 0; 0 subjects
Congenital Bleeding Disorder · Haemophilia B
Primary: Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor) — 10; 3; 0; 0 Haemostatic responses
Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor · Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor · Haemophilia A
Primary: Mean Number of Daily Active Minutes of Physical Activity Performed by Participants (by Age Categories: 12-17, 18-30, and 31-50 Years) Over the Course of the Study…
Congenital Bleeding Disorder · Haemophilia A · Haemophilia B
Primary: Number of Adverse Events (AEs) — 10; 8; 5; 5 events
Severe Hemophilia A
Primary: Pharmacokinetic (PK) Assessment (Area Under the Curve (AUC)) of FVIII:C — 768.8; 671.9; 720.3 h*IU/dL