Congenital Bleeding Disorder, Haemophilia A
Conditions
Brief summary
This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.
Interventions
DRUGturoctocog alfa
No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction 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
* Informed 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 the diagnosis of haemophilia A * Age range is 0 year and above * A decision to initiate treatment with commercially available NovoEight® has been made by the patient/parent and the physician
Exclusion criteria
* Known or suspected allergy to study product(s) or related products * Previous participation in this study. Participation is defined as informed consent obtained * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Adverse Events (AEs) | Week 0- 104 |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of Serious Adverse Events (SAEs) | Week 0- 104 |
| Frequency of Serious Adverse Reactions (SARs) | Week 0- 104 |
| Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively | Week 0- 104 |
| Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None | Week 0- 104 |
| Frequency of Adverse Reactions (ARs) | Week 0- 104 |
| Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient) | Week 0- 104 |
| Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode) | Week 0- 104 |
| Consumption of NovoEight® per month (IU/kg BW/month) for prevention | Week 0- 104 |
| Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen | Week 0- 104 |
| Annualised bleeding rate for patients using NovoEight® for preventive regimen | Week 0- 104 |
Countries
Japan
Outcome results
None listed