30 closest matches · ranked by relevance
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: Proportion of Subjects With Major Response, i.e. Inhibitor Level Falls to Less Than 5 BU/mL Between Weeks 6 to 22 and Remains Below 5 BU/mL at 5-7 Days Following…
Hemophilia B
Primary: Number of Participants With Adverse Events — 5; 5 participants
Hemophilia A or B
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 7; 4; 6; 4 Participants
Severe Hemophilia A
Primary: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors — 17; 11; 28 Participants
Hemophilia A · Prophylaxis of Bleeding
Primary: Overall Number of Participants With Favorable Outcome on the Score-assigned Prophylaxis Regimen — 12 participants
Hemophilia A
Primary: Mean Transformed Annualized Bleed Rate Estimates From Each of the 1-year Prophylaxis Regimens — 1.61; 1.46 (bleeds/year)^(1/2) — p=0.6016
Hemophilia B
Primary: Annualized Bleeding Rate (ABR) for All Bleeding Episodes — 4.19; 1.51 bleeds/year/participants
Hemophilia A
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 2; 5 Participants
Hemophilia A or B
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TEAEs by Severity, and Serious Adverse Events (SAEs) (All Causality and Treatment-Related) — 5; 2…
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
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
Factor VIII Deficiency
Primary: Estimated Annualized Bleeding Rate (ABR) in Arm A: Prophylaxis — 0.71 episodes per participant per year
Hemophilia A With Inhibitors · Hemophilia B With Inhibitors
Primary: Proportion of Successfully Treated Mild/Moderate Bleeding Episodes — .849; .932 Proportion of Success of BEs
Hemophilia A
Primary: Number of Participants With FVIII Inhibitor Development — 11 Participants
Hemophilia A
Primary: Number of Participants With BAX 888-Related Adverse Events (AEs) — 2; 2 Participants
Hemophilia B
Primary: Number of Subjects Who Achieved FIX Level ≥12% — 3; 4; 4; 4 Participants
Hemophilia A
Primary: Change From Baseline in Annualized Number of Bleeding Episodes Irrespective of Exogenous FVIII Replacement Treatment [Annualized Bleeding Rate (ABR) for All Bleeds] in…
Hemophilia A
Primary: Change of the Median Factor VIII (FVIII) Activity — 4.1 IU/dL
Hemophilia A With Inhibitor · Hemophilia B With Inhibitor
Primary: Bleeding Episode Prevention Success — 1.4640 score on a scale
Hemophilia A
Primary: Global Hemostatic Efficacy Assessment Score (GHEA) - Composed of 3 Individual Ratings — 100.0; 100.0; 100.0; 100.0 Percentage of surgeries
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
Severe Hemophilia A
Primary: Incidence Rate of FVIII Inhibitor Development — 0; 0; 0; 0 percentage of participants
Severe Hemophilia A
Primary: Number of Participants With Factor VIII (FVIII) Inhibitor Development — 0 Participants
Hemophilia A
Primary: Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII) — 0; 0; 0; 0 Participants
Hemophilia A
Primary: Percentage of Participants Who Developed Factor VIII (FVIII) Inhibitors — 0 percentage of participants
Blood Coagulation Disorders · Hemophilia A
Primary: Part A - Area Under the Drug Concentration-time Curve (AUC) — 1889.23; 1583.91 Int.units x hours/deciliters (IU*h/dL)
Hemophilia A
Primary: Bleeding Frequency (Number of Total Bleeds) — 0; 54.5 Bleeds — p=<0.0001
Hemophilia A
Primary: Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay — 1158; 1264 (IU·h)/dL — p=0.103
Hemophilia A
Primary: Hemophilia Joint Health Score (HJHS) 2.0 — 3.77 score on a scale