Type 3 Von Willebrand Disease
Conditions
Brief summary
Number of treated bleeds over time
Detailed description
Number of all bleeds over time, Number of treated spontaneous bleeds over time, Number of treated joint bleeds over time, Incidence and severity of adverse events, Incidence and severity of thromboembolic events, Incidence and severity of thrombotic microangiopathy events, Incidence and severity of injection-site reactions, Incidence of adverse events leading to drug discontinuation, Incidence of severe hypersensitivity, anaphylaxis, or anaphylactoid reactions, Changes from baseline in physical examination findings, vital signs, and ECG parameters, Incidence of laboratory abnormalities, Trough plasma concentration of emicizumab, Prevalence and incidence of ADAs to emicizumab
Interventions
DRUGWilate 1000
DRUG1000 IU VWF/1000 IUFVIII
DRUGFanhdi 500 IU powder and solvent for solution for injection.
DRUGHaemate® P 600 IE vWF / 250 IE FVIII
Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung.
DRUGWilate 500
DRUG500 IU VWF/500 IUFVIII
DRUGVoncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
DRUGVoncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion
DRUGWillfact 2000 IU Powder and solvent for solution for injection
DRUGFEIBA 50 U/ml powder and solvent for solution for infusion
DRUGVoncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
DRUGHaemate® P 1200 IE vWF / 500 IE FVIII Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung
DRUGHaemate® P 2400 IE vWF / 1000 IE FVIII Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung
DRUGVoncento 500 IU FVIII /1200 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treated bleeds over time | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of all bleeds over time, Number of treated spontaneous bleeds over time, Number of treated joint bleeds over time, Incidence and severity of adverse events, Incidence and severity of thromboembolic events, Incidence and severity of thrombotic microangiopathy events, Incidence and severity of injection-site reactions, Incidence of adverse events leading to drug discontinuation, Incidence of severe hypersensitivity, anaphylaxis, or anaphylactoid reactions, Changes from baseline in physical examination findings, vital signs, and ECG parameters, Incidence of laboratory abnormalities, Trough plasma concentration of emicizumab, Prevalence and incidence of ADAs to emicizumab | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden
Outcome results
None listed