Clinical trial NCT02207218: To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan
Official title: A Multicentre, Non-interventional Post Marketing Study of Safety and Efficacy of NovoEight® (rFVIII) During Long-Term Treatment of Haemophilia A in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-08-04
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NovoEight® in prevention, treatment of bleeds and prevention of bleeds during and after surgery in previously treated patients (PTPs) and previously untreated patients (PUPs) with haemophilia A in routine clinical setting in Japan.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Adverse Events (AEs)
timeFrame: Week 0- 104
Secondary outcomes:
measure: Frequency of Adverse Reactions (ARs)
timeFrame: Week 0- 104
measure: Frequency of Serious Adverse Events (SAEs)
timeFrame: Week 0- 104
measure: Frequency of Serious Adverse Reactions (SARs)
timeFrame: Week 0- 104
measure: 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
timeFrame: Week 0- 104
measure: Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None
timeFrame: Week 0- 104
measure: Annualised bleeding rate for patients using NovoEight® for preventive regimen
timeFrame: Week 0- 104
measure: Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)
timeFrame: Week 0- 104
measure: Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)
timeFrame: Week 0- 104
measure: Consumption of NovoEight® per month (IU/kg BW/month) for prevention
timeFrame: Week 0- 104
measure: Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen
timeFrame: Week 0- 104
Other outcomes:
Locations:
city: Suginami-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry GCR, 1452
role: STUDY_DIRECTOR
References: