Congenital Bleeding Disorder, Haemophilia A
Conditions
Brief summary
This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).
Interventions
DRUGturoctocog alfa
Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol * Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%) * The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study * A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa
Exclusion criteria
* Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information) * Treatment with any investigational drug within 30 days prior to enrolment into the study * Previous participation in any clinical trial with turoctocog alfa * Treatment with other FVIII products after initiation of treatment with turoctocog alfa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors | Within approximately 7 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of serious adverse reactions reported | During approximately 7 years |
| Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None | Within approximately 7 years |
| Number of adverse reactions reported | During approximately 7 years |
| Annualised bleeding rate for patients using turoctocog alfa for preventive treatment | Within approximately 7 years |
| Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment | Within approximately 7 years |
| Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None | Within approximately 7 years |
Countries
Austria, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, United States
Outcome results
None listed