Congenital Bleeding Disorder, Haemophilia A
Conditions
Brief summary
The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico
Interventions
DRUGturoctocog alfa
Patients will be treated with commercially available turoctocog alfa according to local clinical practice at the discretion of the physician
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * Male and female patients with haemophilia A * Age range is 0 years and above * The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
Exclusion criteria
* Previous participation in this study. Participation is defined as having given informed consent in this study * Known or suspected allergy to turoctocog alfa or related products * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse reactions | 3-36 months after enrollment | Count and % of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in treatment of bleeds | 3-36 months after enrollment | Rated: Excellent, Good, Moderate or none |
| Consumption of turoctocog alfa for prophylaxis | 3-36 months after enrollment | Measured in IU/kg/dose |
| Consumption of turoctocog alfa for treatment of bleeds | 3-36 months after enrollment | Measured in IU/kg/bleeding episode |
| Frequency of adverse events | 3-36 months after enrollment | Count and % of events |
| Number of patients with confirmed inhibitors | 3-36 months after enrollment | Count of presence of inhibitors |
| Number of patients with allergic/hypersensitivity reactions to turoctocog alfa | 3-36 months after enrollment | Count of episodes |
| Number of bleeding episodes | 3-36 months after enrollment | Count of episodes |
| Consumption of turoctocog alfa for surgery and post-surgical period | 3-36 months after enrollment | Measured in IU/kg |
Countries
Mexico
Outcome results
None listed