To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan

N/ACompletedNCT02207218

Novo Nordisk A/S40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A

Interventions

turoctocog alfaDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Novo Nordisk Investigational Site

Suginami-ku, Tokyo, Japan

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Frequency of Adverse Events (AEs)

Time frame: Week 0- 104

Secondary Outcomes

Frequency of Adverse Reactions (ARs)

Time frame: Week 0- 104

Frequency of Serious Adverse Events (SAEs)

Time frame: Week 0- 104

Frequency of Serious Adverse Reactions (SARs)

Time frame: 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

Time frame: 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

Time frame: Week 0- 104

Annualised bleeding rate for patients using NovoEight® for preventive regimen

Time frame: Week 0- 104

Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)

Time frame: Week 0- 104

Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)

Time frame: Week 0- 104

Consumption of NovoEight® per month (IU/kg BW/month) for prevention

Time frame: Week 0- 104

Data from ClinicalTrials.gov

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