N/A N=48 Gingival Bleeding and Von Willebrand Disease Typ 2 and 3
Gingival Bleeding · Von Willebrand Diseases
Primary: Bleeding on Probing (BOP) — 14.5; 12.3 percentage of sites
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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 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…
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
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=35 Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency
Congenital Afibrinogenemia · Congenital Hypofibrinogenemia
Primary: Single-dose Pharmacokinetics (PK) of BT524: Terminal Elimination Half-life (t1/2) for Fibrinogen Antigen — 67.9 hours
Phase 3 N=25 Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
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
Phase 4 N=60 Fibrinogen Concentrate vs Cryoprecipitate
Congenital Heart Disease
Primary: Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival. — 5; 4 ADT units
Phase 3 N=20 Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial
Von Willebrand Diseases · Postpartum Hemorrhage
Primary: Volume of Quantitative Blood Loss at Delivery — 727.0; 539.7 mL
Phase 2 N=122 Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
Chronic HCV Infection
Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 99.0; 100.0; 100.0; 83.3 percentage of participants
N/A N=56 Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment
Von Willebrand Diseases
Primary: Total Annualized Bleeding Rate (TABR) — 29.13 Bleeding events per year
N/A N=265 Type 3 Von Willebrand International Registries Inhibitor Prospective Study
Type 3 Von Willebrand's Disease
Primary: Centralized Factor VIII (FVIII) Procoagulant Activity (FVIII:C) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis — 2.42 IU/dL
Phase 4 N=437 Fibrinogen in Haemorrhage of Delivery
Post-Partum Hemorrhage
Primary: Failure Rate of PPH Management — 75; 80; 92; 92 Participants — p=0.9563
Phase 3 N=9 A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 Years
Factor X Deficiency
Primary: The Number of Participants With Excellent Reduction in Bleeding When Given FACTOR X as Routine Prophylaxis Over 6 Months — 9 Participants
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 1 N=24 Thrombosomes® in Bleeding Thrombocytopenic Patients
Thrombocytopenia · Hematologic Diseases · Bone Marrow Aplasia
Primary: Number of Patients With Treatment-Emergent Adverse Events (TEAE) — 7; 6; 5 Participants
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=35 A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)
Von Willebrand Disease (VWD)
Primary: Spontaneous Annualized Bleeding Rate (sABR) — 1.430; 1.040; 0.000; 3.022 spontaneous bleeds per year
Phase 2 N=10 Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B
Hemophilia B
Primary: Number of Participants With Adverse Events — 5; 5 participants
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
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 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 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 4 N=1 Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
Hemophilia B
Primary: Number of Participants Reporting Efficacy
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 3 N=6 Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Number of Treatment Emergent (Serious and Non-serious) Adverse Events — 100; 2; 98 number of events
Phase 2 N=36 A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
Haemostasis · Haemophilia A
Primary: The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset — 43; 13; 14 Episodes
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
N/A N=24 Coagulation Factor Changes Associated With Postpartum Hysterectomies
Obstetric Labor Complications · Hemorrhage · Complications; Cesarean Section
Primary: Fibrinogen Level at 2 Hours After Delivery — 186; 418 mg/dL — p=<0.05