Phase 4 N=21 Prophylaxis Regimen for Hemophilia A Patients
Hemophilia A · Prophylaxis of Bleeding
Primary: Overall Number of Participants With Favorable Outcome on the Score-assigned Prophylaxis Regimen — 12 participants
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N/A N=22 Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy
Hemophilia · Hemophilic Arthropathy
Primary: Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months — 5.0; 4.1; 2.5; 1.8 scores on a scale — p=<0.05
Phase 4 N=73 Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
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
Phase 3 N=134 A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A
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…
Phase 2 N=23 Rituximab to Treat Severe Hemophilia A
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…
N/A N=104 Multidisciplinary Evaluation of Patients With Hemophilia
Haemophilia
Primary: Assess the Joint Damage — 0.36; 0 points
Phase 2 N=51 Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
Congenital Bleeding Disorder · Haemophilia A · Haemophilia B
Primary: Number of Adverse Events (AEs) — 10; 8; 5; 5 events
Phase 3 N=5 Study of TAK-672 in Participants With Acquired Hemophilia A
Acquired Hemophilia A
Primary: Percentage of Participants With Severe Bleeding Episodes Who Demonstrated Response to TAK-672 Therapy at 24 Hours After the Initiation of Treatment — 100 percentage of…
Phase 4 N=50 Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
Severe Hemophilia A
Primary: Number of Participants With Factor VIII (FVIII) Inhibitor Development — 0 Participants
Phase 3 N=110 Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Severe Hemophilia A
Primary: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors — 17; 11; 28 Participants
Phase 4 N=26 Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
Hemophilia A
Primary: Initial Recovery — 1.7; 1.6; 1.8 IU/dL per IU/kg — p=0.1662
Phase 4 N=30 Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Hemophilia A
Primary: Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period — 56.00 Bleeds
Phase 4 N=50 Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Hemophilia A Patients
Hemophilia A
Primary: Percentage of Participants Who Developed Factor VIII (FVIII) Inhibitors — 0 percentage of participants
Phase 1 N=29 Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
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
Phase 3 N=37 A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A
Hemophilia A
Primary: Total Annualized Bleeding Rates (ABR) — 4.1 bleeds per year
Phase 3 N=16 Prospective Biomarkers of Bone Metabolism in Hemophilia A
Hemophilia · Bone Disease
Primary: Bone Biomarker Density (BMD) — -0.74; -0.16; -0.16 Z-Score
Phase 3 N=120 A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A
Hemophilia A
Primary: Number of Participants With FVIII Inhibitor Development — 11 Participants
Phase 4 N=63 Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery
Hemophilia A
Primary: Cumulative Packed Red Blood Cell (PRBC) Volume in the Drainage Fluid During the First 24 Hours Following Surgery in Subjects Receiving ADVATE (rAHF-PFM) by Bolus (BI) or…
Phase 2 N=14 Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A
Hemophilia A
Primary: Hemophilia Joint Health Score (HJHS) 2.0 — 3.77 score on a scale
Phase 3 N=22 Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
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
Phase 3 N=80 A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis
Hemophilia
Primary: Estimated Annualized Bleeding Rate (ABR) — 7.482; 2.908 episodes per participant per year — p==0.0008
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 4 N=56 Canadian Hemophilia Prophylaxis Study
Severe Hemophilia A
Primary: Number of Participants Who Developed Target Joint Bleeding — 17 Participants
Phase 3 N=113 A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors
Hemophilia A
Primary: Model-Based Annualized Bleed Rate (ABR) for Treated Bleeds, Arm A: Emicizumab Versus Arm B: No Prophylaxis — 2.9; 23.3 treated bleeds per year — p=<0.0001
N/A N=17 Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy
Hemophilia
Primary: Assessment of Bilateral Index of Maximal Peak Force — -40.86 percentage
N/A N=66 An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia
Hemophilia A · Hemophilia B · Factor VIII Deficiency
Primary: MVPA — 48; 55 minutes per day — p=0.32
Phase 3 N=36 Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A
Severe Hemophilia A
Primary: Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months — 0.188 Bleeds per month
Phase 4 N=23 Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A
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
N/A N=103 An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment
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…
Phase 3 N=36 A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood
Treatment of Bleeding · Prophylaxis of Bleeding · Hemophilia A
Primary: Adverse Events of Special Interest (AESI) Hypersensitivity and Loss of Efficacy Associated With the First 4 Exposure Days (EDs) Leading to Discontinuation — 1 Participants