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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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=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 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 2 N=11 A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A
Hemophilia A
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 2; 5 Participants
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 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=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 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 2 N=22 Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
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)
Phase 3 N=246 An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
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
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=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 3 N=84 Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A
Congenital Hemophilia A
Primary: Treatment Success — 96.3 Percentage of treated bleeding events
Phase 3 N=165 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A
Severe Hemophilia A
Primary: Incidence Rate of FVIII Inhibitor Development — 0; 0; 0; 0 percentage of participants
Phase 3 N=108 An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
Hemophilia A
Primary: Percentage of Participants With Confirmed Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay — 31.11 percentage of participants
Phase 3 N=25 A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa
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
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…
Phase 3 N=29 Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A
Acquired Hemophilia A
Primary: Percentage of Serious Bleeding Episodes Responsive to OBI-1 — 100 percentage of serious bleeding episodes — p=<0.001
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 1 N=11 Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia
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
Phase 2 N=4 Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors
Adeno-Associated Virus (AAV) · Blood Coagulation Disorder · Blood Coagulation Disorders, Inherited
Primary: Number of Participants With Adverse Events (AEs) — 4 Participants
Phase 3 N=28 Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
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)
Phase 3 N=55 Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients
Hemophilia A
Primary: Factor VIII Inhibitor Development — 29.1 percentage
Phase 3 N=240 Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Hemophilia A
Primary: Number of Participants With Any Positive Inhibitor Development — 0; 0; 0 Participants
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=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 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 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