To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan
- Registration Number
- NCT02207218
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NovoEight® turoctocog alfa -
- Primary Outcome Measures
Name Time Method Frequency of Adverse Events (AEs) Week 0- 104
- Secondary Outcome Measures
Name Time Method Consumption of NovoEight® per month (IU/kg BW/month) for prevention Week 0- 104 Frequency of Serious Adverse Reactions (SARs) 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 Annualised bleeding rate for patients using NovoEight® for preventive regimen 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® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen Week 0- 104 Frequency of Adverse Reactions (ARs) 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 Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode) Week 0- 104 Frequency of Serious Adverse Events (SAEs) Week 0- 104
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan